All-in-one computer + Pre-installed Software ACC00008Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07290113780231), received between Jan 14, 2022 and Dec 24, 2023 — classified as 18 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A BURR WAS BEING NAVIGATED WITH A 5-6MM UNIVERSAL SWIVEL ADAPTER ATTACHED. ABOUT AN HOUR INTO NAVIGATION, THE SCRUB TECH INFORMED THE REP THAT HE PLACED THE DRILL DOWN ON THE MAYO STAND. WHEN HE WENT TO PICK IT BACK UP FROM THE MAYO, THE TRIGGER WAS LOOSE AND CAME OUT. THE SCRUB SET THE TRIGGER AND THE INTERNAL SPRING ASIDE, AND THE ADAPTER WAS REPLACED WITH ANOTHER FOR THE REST OF THE CASE. NO HARM TO THE PATIENT HAD OCCURRED DURING THE PROCEDURE. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18389933 ↗
• MalfunctionDec 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A BURR WAS BEING NAVIGATED WITH A 5-6MM UNIVERSAL SWIVEL ADAPTER ATTACHED. ABOUT AN HOUR INTO NAVIGATION, THE SCRUB TECH INFORMED THE REP THAT HE PLACED THE DRILL DOWN ON THE MAYO STAND. WHEN HE WENT TO PICK IT BACK UP FROM THE MAYO, THE TRIGGER WAS LOOSE AND CAME OUT. THE SCRUB SET THE TRIGGER AND THE INTERNAL SPRING ASIDE, AND THE ADAPTER WAS REPLACED WITH ANOTHER FOR THE REST OF THE CASE. NO HARM TO THE PATIENT HAD OCCURRED DURING THE PROCEDURE. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18389932 ↗
• MalfunctionDec 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON HAD DRILLED 3 PILOT HOLES ON THE LEFT SIDE. WHEN HE MOVED OVER TO START DRILLING THE RIGHT SIDE, THE TRIGGER ON THE SWIVEL ADAPTER FELL OFF THE ADAPTER. THE SURGEON RETRIEVED THE TRIGGER. BEFORE MOVING FORWARD WITH THE CASE, HE COMPLETED A LANDMARK CHECK WHICH CONFIRMED THE TOOL'S ACCURACY AND PROCEEDED WITH THE CASE. AFTER THE CASE WAS COMPLETED, THE TRIGGER WAS PLACED BACK INTO THE SLOT TO REMOVE IT FROM THE DRILL ATTACHMENT. THE TRIGGER BECAME LODGED AND INOPERABLE. SPD CAN REMOVE IT FROM THE ADAPTER. NO HARM TO THE PATIENT HAD OCCURRED DURING THE PROCEDURE. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341749 ↗
• MalfunctionDec 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON HAD DRILLED 3 PILOT HOLES ON THE LEFT SIDE. WHEN HE MOVED OVER TO START DRILLING THE RIGHT SIDE, THE TRIGGER ON THE SWIVEL ADAPTER FELL OFF THE ADAPTER. THE SURGEON RETRIEVED THE TRIGGER. BEFORE MOVING FORWARD WITH THE CASE, HE COMPLETED A LANDMARK CHECK WHICH CONFIRMED THE TOOL'S ACCURACY AND PROCEEDED WITH THE CASE. AFTER THE CASE WAS COMPLETED, THE TRIGGER WAS PLACED BACK INTO THE SLOT TO REMOVE IT FROM THE DRILL ATTACHMENT. THE TRIGGER BECAME LODGED AND INOPERABLE. SPD CAN REMOVE IT FROM THE ADAPTER. NO HARM TO THE PATIENT HAD OCCURRED DURING THE PROCEDURE. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341748 ↗
• MalfunctionOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON WAS USING A BURR TO NAVIGATE AND BURR HIS STARTING POINTS FOR FACETECTOMIES WHEN THE BUTTON ON THE ADAPTER POPPED OUT OF THE ADAPTER. UPON TAKING AP FLUORO IMAGES THE SURGEON NOTICED A SMALL SPRING THAT MUST HAVE BELONGED TO THE ADAPTER IN THE IMAGING AND TOOK IT OUT OF THE PATIENT. THE ADAPTER WAS REMOVED FROM THE TRAY AND SENT OUT FOR FURTHER INVESTIGATION. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997291 ↗
• MalfunctionOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON WAS USING A BURR TO NAVIGATE AND BURR HIS STARTING POINTS FOR FACETECTOMIES WHEN THE BUTTON ON THE ADAPTER POPPED OUT OF THE ADAPTER. UPON TAKING AP FLUORO IMAGES THE SURGEON NOTICED A SMALL SPRING THAT MUST HAVE BELONGED TO THE ADAPTER IN THE IMAGING AND TOOK IT OUT OF THE PATIENT. THE ADAPTER WAS REMOVED FROM THE TRAY AND SENT OUT FOR FURTHER INVESTIGATION. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997249 ↗
• InjurySep 21, 2023Use of Device Problem; Use of Device Problem

  AFTER AN XLINK REGISTRATION, THE SURGEON COMPLETED A LANDMARK CHECK WITH A PROBE AND CONFIRMED ACCURACY. THE SURGEON THEN BROUGHT IN A BURR AND COMMENTED THAT IT WAS NOT ACCURATE. THE BURR WAS RECALIBRATED, BUT THE SURGEON STILL FELT THAT IT WAS INACCURATE. THE SURGEON PROCEEDED WITH THE LEFT L4-5 SCREWS AND TOOK FLUORO SHOTS. HE WAS UNHAPPY WITH SCREW PLACEMENT AND DECIDED TO RE-SPIN AND RE-REGISTER USING XLINK. HE CONFIRMED THE SECOND REGISTRATION AND ACCURACY OF THE BURR WITH LANDMARK CHECKS AND REPOSITIONED THE LEFT L4-5 SCREWS AND THEN COMPLETED THE RIGHT SIDE. THE REDIRECTED SCREWS, USING THE XVS SYSTEM AND THE SAME CALIBRATED TOOLS, WERE FOUND TO BE POSITIONED ACCURATELY, AS CONFIRMED WITH FLUORO. THE FACT THAT RE-SPINNING AND RE-REGISTRATION, USING THE SAME CALIBRATED TOOLS, RESULTED IN ACCURATE SCREW POSITIONING, SUGGESTS THAT THERE WAS A SLIGHT MOVEMENT OF EITHER THE PATIENT MARKER OR THE PATIENT AFTER THE FIRST REGISTRATION COMPLETION AND INSTRUMENTATION. NONE OF THE FINDINGS INDICATE A MALFUNCTION OF THE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE EVENT WAS SOLELY THE RESULT OF A USER ERROR, HOWEVER, THIS ERROR LED TO THE REPOSITIONING OF THE SCREWS, WHICH CONSIDERED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787442 ↗
• InjurySep 21, 2023Use of Device Problem; Use of Device Problem

  AFTER AN XLINK REGISTRATION, THE SURGEON COMPLETED A LANDMARK CHECK WITH A PROBE AND CONFIRMED ACCURACY. THE SURGEON THEN BROUGHT IN A BURR AND COMMENTED THAT IT WAS NOT ACCURATE. THE BURR WAS RECALIBRATED, BUT THE SURGEON STILL FELT THAT IT WAS INACCURATE. THE SURGEON PROCEEDED WITH THE LEFT L4-5 SCREWS AND TOOK FLUORO SHOTS. HE WAS UNHAPPY WITH SCREW PLACEMENT AND DECIDED TO RE-SPIN AND RE-REGISTER USING XLINK. HE CONFIRMED THE SECOND REGISTRATION AND ACCURACY OF THE BURR WITH LANDMARK CHECKS AND REPOSITIONED THE LEFT L4-5 SCREWS AND THEN COMPLETED THE RIGHT SIDE. THE REDIRECTED SCREWS, USING THE XVS SYSTEM AND THE SAME CALIBRATED TOOLS, WERE FOUND TO BE POSITIONED ACCURATELY, AS CONFIRMED WITH FLUORO. THE FACT THAT RE-SPINNING AND RE-REGISTRATION, USING THE SAME CALIBRATED TOOLS, RESULTED IN ACCURATE SCREW POSITIONING, SUGGESTS THAT THERE WAS A SLIGHT MOVEMENT OF EITHER THE PATIENT MARKER OR THE PATIENT AFTER THE FIRST REGISTRATION COMPLETION AND INSTRUMENTATION. NONE OF THE FINDINGS INDICATE A MALFUNCTION OF THE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE EVENT WAS SOLELY THE RESULT OF A USER ERROR, HOWEVER, THIS ERROR LED TO THE REPOSITIONING OF THE SCREWS, WHICH CONSIDERED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787440 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  THIS CASE WAS A REVISION CASE - L5-S1 BILATERAL SCREWS WERE PREVIOUSLY INSTRUMENTED. L4 WAS INSTRUMENTED USING THE XVS SYSTEM. IN AN OPEN PROCEDURE USING A PERC PIN, THE SURGEON WAS NOTICED TO BUMP INTO PATIENT FIXATION BEFORE INSTRUMENTATION. THE REP NOTIFIED THE SURGEON OF THE BUMP; HOWEVER, THE SURGEON DID NOT WANT TO RE-SPIN. THE SURGEON OPTED TO CONDUCT A THOROUGH ANATOMY CHECK AT MULTIPLE LANDMARKS INSTEAD, TO VERIFY THE REGISTRATION ACCURACY, AND OPTED TO CONTINUE WITH THE NAVIGATION. L4 SCREWS WERE FOUND TO BE POSITIONED INACCURATELY ON AP/LATERAL X-RAY IMAGES. L4 SCREWS WERE REMOVED AND REPLACED ACCURATELY UNDER FLUORO. THE PATIENT IS DOING WELL. THE INVESTIGATION CONCLUDED THAT THE MAIN CAUSE FOR THE DISCREPANCY BETWEEN THE XVS VIRTUAL DISPLAY AND ACTUAL SCREW PLACEMENT, WHICH LED TO INACCURATE SCREW PLACEMENT, IS DUE TO MOVEMENT OF THE FIXATION POINT, WHICH OCCURRED DUE TO THE SURGEON BUMPING INTO IT. THE SURGEON DID NOT FOLLOW THE USER MANUAL INSTRUCTIONS AND EVALUATED THE ACCURACY OF ONLY ANATOMICAL LANDMARKS, PERCUTANEOUSLY. A SCREW THAT IS NOT POSITIONED IN THE PEDICLE AND THAT NEEDED TO BE REMOVED AND REPLACED IS CONSIDERED ACCORDING TO THE ABOVE DEFINITION AS "SERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17496262 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  THIS CASE WAS A REVISION CASE - L5-S1 BILATERAL SCREWS WERE PREVIOUSLY INSTRUMENTED. L4 WAS INSTRUMENTED USING THE XVS SYSTEM. IN AN OPEN PROCEDURE USING A PERC PIN, THE SURGEON WAS NOTICED TO BUMP INTO PATIENT FIXATION BEFORE INSTRUMENTATION. THE REP NOTIFIED THE SURGEON OF THE BUMP; HOWEVER, THE SURGEON DID NOT WANT TO RE-SPIN. THE SURGEON OPTED TO CONDUCT A THOROUGH ANATOMY CHECK AT MULTIPLE LANDMARKS INSTEAD, TO VERIFY THE REGISTRATION ACCURACY, AND OPTED TO CONTINUE WITH THE NAVIGATION. L4 SCREWS WERE FOUND TO BE POSITIONED INACCURATELY ON AP/LATERAL X-RAY IMAGES. L4 SCREWS WERE REMOVED AND REPLACED ACCURATELY UNDER FLUORO. THE PATIENT IS DOING WELL. THE INVESTIGATION CONCLUDED THAT THE MAIN CAUSE FOR THE DISCREPANCY BETWEEN THE XVS VIRTUAL DISPLAY AND ACTUAL SCREW PLACEMENT, WHICH LED TO INACCURATE SCREW PLACEMENT, IS DUE TO MOVEMENT OF THE FIXATION POINT, WHICH OCCURRED DUE TO THE SURGEON BUMPING INTO IT. THE SURGEON DID NOT FOLLOW THE USER MANUAL INSTRUCTIONS AND EVALUATED THE ACCURACY OF ONLY ANATOMICAL LANDMARKS, PERCUTANEOUSLY. A SCREW THAT IS NOT POSITIONED IN THE PEDICLE AND THAT NEEDED TO BE REMOVED AND REPLACED IS CONSIDERED ACCORDING TO THE ABOVE DEFINITION AS "SERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17496261 ↗
• InjuryAug 2, 2023Use of Device Problem; Use of Device Problem

  IN AN MIS PROCEDURE, A TALL CLAMP WAS PLACED ON THE SP OF T7, AND ITS STABILITY WAS CONFIRMED. UPON INCISION, AN INITIAL LANDMARK CHECK CONFIRMED ANATOMY WITH TACTILE FEEDBACK FROM THE SURGEON, AND THE SCREWS WERE INSTRUMENTED BILATERALLY ON T7 AND T6. A LANDMARK CHECK WAS PERFORMED AT T5, AND THE SURGEON NOTED THAT TACTILE FEEDBACK WAS NOT CORRELATING WITH THE NAV IMAGE SCREEN. AP AND LATERAL IMAGES OF SCREWS INSTRUMENTED SHOWED THAT SCREWS WERE PLACED HIGH AND NOT IN THE PEDICLE LIKE ON THE NAV IMAGES. SURGEON ELECTED NOT TO RE-SPIN AND THE SCREWS WERE REVISED UNDER C-ARM FLUORO, AS WELL AS THE REST OF THE CONSTRUCT. A THOROUGH ANALYSIS WAS CONDUCTED AND SHOWED THE VIRTUAL TRAJECTORIES PRESENTED BY THE XVS SYSTEM APPEAR HIGH BUT NOT IN THE DISK SPACE AS THE SCREWS. HENCE, THERE SEEMS TO BE A DISCREPANCY BETWEEN VIRTUAL AND ACTUAL PLACEMENT. TWO ISSUES WERE FOUND AS POSSIBLE CAUSES FOR THE DISCREPANCY BETWEEN THE REPORTED DEVIATED SCREWS AND THE INCORRECT NAVIGATION INDICATION: 1. MOVEMENT OF X-MARKER POSITION IN RELATION TO PATIENT MARKER DURING REGISTRATION, DUE TO "BREAKING BREATHING." 2. MOVEMENT OF CLAMP DURING INSTRUMENTATION DUE TO BUMPING INTO THE CLAMP NONE OF THE FINDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446953 ↗
• InjuryAug 2, 2023Use of Device Problem; Use of Device Problem

  IN AN MIS PROCEDURE, A TALL CLAMP WAS PLACED ON THE SP OF T7, AND ITS STABILITY WAS CONFIRMED. UPON INCISION, AN INITIAL LANDMARK CHECK CONFIRMED ANATOMY WITH TACTILE FEEDBACK FROM THE SURGEON, AND THE SCREWS WERE INSTRUMENTED BILATERALLY ON T7 AND T6. A LANDMARK CHECK WAS PERFORMED AT T5, AND THE SURGEON NOTED THAT TACTILE FEEDBACK WAS NOT CORRELATING WITH THE NAV IMAGE SCREEN. AP AND LATERAL IMAGES OF SCREWS INSTRUMENTED SHOWED THAT SCREWS WERE PLACED HIGH AND NOT IN THE PEDICLE LIKE ON THE NAV IMAGES. SURGEON ELECTED NOT TO RE-SPIN AND THE SCREWS WERE REVISED UNDER C-ARM FLUORO, AS WELL AS THE REST OF THE CONSTRUCT. A THOROUGH ANALYSIS WAS CONDUCTED AND SHOWED THE VIRTUAL TRAJECTORIES PRESENTED BY THE XVS SYSTEM APPEAR HIGH BUT NOT IN THE DISK SPACE AS THE SCREWS. HENCE, THERE SEEMS TO BE A DISCREPANCY BETWEEN VIRTUAL AND ACTUAL PLACEMENT. TWO ISSUES WERE FOUND AS POSSIBLE CAUSES FOR THE DISCREPANCY BETWEEN THE REPORTED DEVIATED SCREWS AND THE INCORRECT NAVIGATION INDICATION: 1. MOVEMENT OF X-MARKER POSITION IN RELATION TO PATIENT MARKER DURING REGISTRATION, DUE TO "BREAKING BREATHING" 2. MOVEMENT OF CLAMP DURING INSTRUMENTATION DUE TO BUMPING INTO THE CLAMP NONE OF THE FINDINGS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442196 ↗
• MalfunctionJul 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGERY: REMOVAL OF HARDWARE L2-L5, NEW SCREWS PLACED WITH XVISION FROM T9-S1. DURING INSTRUMENTATION, A NAVLOCK TOOL ADAPTOR WAS DETACHED FROM THE GEARSHIFT TOOL THAT WAS FIXATED ON IT. VISUAL INSPECTION OF THE ADAPTER REVEALED THAT THE ADAPTER WAS DAMAGED. A NEW ADAPTER WAS PLACED ONTO THE GEARSHIFT TOOL AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. POST-OPERATIVELY, ONE OF THE STAINLESS-STEEL BALLS OF THE ADAPTERS WAS FOUND IN A STERILE AREA, NEAR THE OTHER TOOLS. AN O-ARM SPIN AND FLAT PANEL X-RAY WERE PERFORMED, AND THE SURGEON AND TEAM DID NOT SEE ANY OTHER BALLS WITHIN THE PATIENT'S BODY. AS A RESULT, ALL SITE NAVLOCK ADAPTORS WERE INSPECTED, AND 8 WERE FOUND DAMAGED WITH MISSING ONE, OR TWO, BALLS AND BROKEN PEEK. THE ADAPTERS ARE MANUFACTURED FROM WELL-KNOWN USED MATERIALS IN MEDICAL DEVICES. ALL 9 DAMAGED ADAPTERS WERE QUARANTINED AT THE SITE. FOUR ADDITIONAL ADAPTORS AT THE SITE WERE FOUND TO BE UNDAMAGED. THE COMPANY TRIED TO REPRODUCE THE EVENT USING SIMILAR TOOLS AND ADAPTORS FOLLOWING A SIMILAR CLINICAL WORKFLOW OF THE SURGEON WITH NO SUCCESS. A MALFUNCTION DURING THE MANUFACTURING PROCESS WAS ALSO RULED OUT, AS WELL AS A DAMAGED BATCH. ALL OTHER ADAPTERS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379384 ↗
• MalfunctionJul 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGERY: REMOVAL OF HARDWARE L2-L5, NEW SCREWS PLACED WITH XVISION FROM T9-S1. DURING INSTRUMENTATION, A NAVLOCK TOOL ADAPTOR WAS DETACHED FROM THE GEARSHIFT TOOL THAT WAS FIXATED ON IT. VISUAL INSPECTION OF THE ADAPTER REVEALED THAT THE ADAPTER WAS DAMAGED. A NEW ADAPTER WAS PLACED ONTO THE GEARSHIFT TOOL AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. POST-OPERATIVELY, ONE OF THE STAINLESS-STEEL BALLS OF THE ADAPTERS WAS FOUND IN A STERILE AREA, NEAR THE OTHER TOOLS. AN O-ARM SPIN AND FLAT PANEL X-RAY WERE PERFORMED, AND THE SURGEON AND TEAM DID NOT SEE ANY OTHER BALLS WITHIN THE PATIENT'S BODY. AS A RESULT, ALL SITE NAVLOCK ADAPTORS WERE INSPECTED, AND 8 WERE FOUND DAMAGED WITH MISSING ONE, OR TWO, BALLS AND BROKEN PEEK. THE ADAPTERS ARE MANUFACTURED FROM WELL-KNOWN USED MATERIALS IN MEDICAL DEVICES. ALL 9 DAMAGED ADAPTERS WERE QUARANTINED AT THE SITE. FOUR ADDITIONAL ADAPTORS AT THE SITE WERE FOUND TO BE UNDAMAGED. THE COMPANY TRIED TO REPRODUCE THE EVENT USING SIMILAR TOOLS AND ADAPTORS FOLLOWING A SIMILAR CLINICAL WORKFLOW OF THE SURGEON WITH NO SUCCESS. A MALFUNCTION DURING THE MANUFACTURING PROCESS WAS ALSO RULED OUT, AS WELL AS A DAMAGED BATCH. ALL OTHER ADAPTERS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377667 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  THE SURGEON UTILIZED A PERC PIN AND XLINK FOR REGISTRATION. HE PLACED LEFT-SIDED SCREWS (L1-T9), THEN PROCEEDED TO PLACE THE RIGHT L2 SCREW BEFORE CHECKING THE SCREWS. NEUROMONITORING NOTED DECREASED L LOWER EXTREMITY SENSORY AND MOTOR SIGNALS FOLLOWING T9 SCREW PLACEMENT. UPON CONFIRMATION SCAN COMPLETION, 4 SCREWS WERE NOTED TO BE MEDIAL (LEFT T9, T10, T12, L1) AND THE RIGHT L2 SCREW WAS LATERAL. ALL 5 SCREWS WERE REMOVED AND REDIRECTED FOLLOWING THE FIXATION OF A CLAMP TO THE SPINOUS PROCESS AND RE-SCANNING. THE SURGEON DID NOT FEEL IT WAS A SYSTEM OR SOFTWARE ISSUE BUT FELT AS THOUGH THE RIGIDITY OF THE PERC PIN AND SOFTNESS OF THE PATIENT'S BONE LED TO THE ISSUE THAT OCCURRED. FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED ABOUT WEAKNESS IN L LEG BUT WAS ABLE TO MOVE HER FOOT. PATIENT STATUS WAS REPORTED TO IMPROVE. THE PROBABLE ROOT CAUSE FOR THE INACCURATE SCREWS' PLACEMENT WAS A MOVEMENT OF THE PERC PIN INSERTED IN THE PATIENT'S BONE COMBINED WITH A SOFT BONE STRUCTURE OF THE PATIENT. USING A CLAMP INSTEAD OF A PERC PIN RESULTED IN THE ACCURATE PLACEMENT OF ALL RE-DIRECTED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941017 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  THE SURGEON UTILIZED A PERC PIN AND XLINK FOR REGISTRATION. HE PLACED LEFT-SIDED SCREWS (L1-T9), THEN PROCEEDED TO PLACE THE RIGHT L2 SCREW BEFORE CHECKING THE SCREWS. NEUROMONITORING NOTED DECREASED L LOWER EXTREMITY SENSORY AND MOTOR SIGNALS FOLLOWING T9 SCREW PLACEMENT. UPON CONFIRMATION SCAN COMPLETION, 4 SCREWS WERE NOTED TO BE MEDIAL (LEFT T9, T10, T12, L1) AND THE RIGHT L2 SCREW WAS LATERAL. ALL 5 SCREWS WERE REMOVED AND REDIRECTED FOLLOWING THE FIXATION OF A CLAMP TO THE SPINOUS PROCESS AND RE-SCANNING. THE SURGEON DID NOT FEEL IT WAS A SYSTEM OR SOFTWARE ISSUE BUT FELT AS THOUGH THE RIGIDITY OF THE PERC PIN AND SOFTNESS OF THE PATIENT'S BONE LED TO THE ISSUE THAT OCCURRED. FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED ABOUT WEAKNESS IN L LEG BUT WAS ABLE TO MOVE HER FOOT. PATIENT STATUS WAS REPORTED TO IMPROVE. THE PROBABLE ROOT CAUSE FOR THE INACCURATE SCREWS' PLACEMENT WAS A MOVEMENT OF THE PERC PIN INSERTED IN THE PATIENT'S BONE COMBINED WITH A SOFT BONE STRUCTURE OF THE PATIENT. USING A CLAMP INSTEAD OF A PERC PIN RESULTED IN THE ACCURATE PLACEMENT OF ALL RE-DIRECTED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941009 ↗
• InjuryApr 13, 2023Use of Device Problem; Use of Device Problem

  A THORACO-LUMBAR OPEN SURGERY WAS PLANNED ON T10-L4. 2 SCREWDRIVERS WERE CALIBRATED TO BE USED DURING THE CASE (T1 AND T4). INVESTIGATION REVEALED DIFFICULTIES IN THE CALIBRATION AND VERIFICATION OF BOTH SCREWDRIVERS THAT WERE USED FOR PLACING THE 14 SCREWS. ONLY ONE OF THE INSTRUMENTED SCREWS WAS FOUND TO BE HIGH COMPARED TO THE EXPECTED TRAJECTORY (RL4). A CONFIRMATION SCAN SHOWED RIGHT L4 SCREW WAS HIGH IN THE PEDICLE, AND THE SURGEON FELT HAD A DIFFERENT TRAJECTORY THAN SHOWN ON NAVIGATION. THE SURGEON OPTED TO REDIRECT WITH NAVIGATION. AFTER REDIRECTING AND CONFIRMATION SCAN THE SCREW WAS STILL HIGH AND THE SURGEON OPTED TO FREEHAND SCREW. IN THIS CASE, THE USER USED DEPUY EXPEDIUM SCREWS. IF THE SLEEVE IS NOT PERFECTLY ALIGNED, THE SCREW ISN'T FIRMLY FIXATED, THUS THE SCREW WHILE FIXATED TO THE SCREWDRIVER IS IDENTIFIED AS BENT BY THE XVISION SW, LEADING TO A FAILURE IN VERIFICATION. THE INVESTIGATION CONCLUDED THAT THE MAIN CAUSE OF INACCURACY WAS THE SCREW SKIVING. ADDITIONALLY, IT MAY BE THAT THE TULIP HEAD WASN'T COMPLETELY FIXATED DURING THE INSERTION, LEADING TO A DISCREPANCY BETWEEN THE DISPLAYED VIRTUAL SCREW TRAJECTORY AND THE ACTUAL PEDICLE. BETTER CLARIFICATION REG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734659 ↗
• InjuryApr 13, 2023Use of Device Problem; Use of Device Problem

  A THORACO-LUMBAR OPEN SURGERY WAS PLANNED ON T10-L4. 2 SCREWDRIVERS WERE CALIBRATED TO BE USED DURING THE CASE (T1 AND T4). INVESTIGATION REVEALED DIFFICULTIES IN THE CALIBRATION AND VERIFICATION OF BOTH SCREWDRIVERS THAT WERE USED FOR PLACING THE 14 SCREWS. ONLY ONE OF THE INSTRUMENTED SCREWS WAS FOUND TO BE HIGH COMPARED TO THE EXPECTED TRAJECTORY (RL4). A CONFIRMATION SCAN SHOWED RIGHT L4 SCREW WAS HIGH IN THE PEDICLE, AND THE SURGEON FELT HAD A DIFFERENT TRAJECTORY THAN SHOWN ON NAVIGATION. THE SURGEON OPTED TO REDIRECT WITH NAVIGATION. AFTER REDIRECTING AND CONFIRMATION SCAN THE SCREW WAS STILL HIGH AND THE SURGEON OPTED TO FREEHAND SCREW. IN THIS CASE, THE USER USED DEPUY EXPEDIUM SCREWS. IF THE SLEEVE IS NOT PERFECTLY ALIGNED, THE SCREW ISN'T FIRMLY FIXATED, THUS THE SCREW WHILE FIXATED TO THE SCREWDRIVER IS IDENTIFIED AS BENT BY THE XVISION SW, LEADING TO A FAILURE IN VERIFICATION. THE INVESTIGATION CONCLUDED THAT THE MAIN CAUSE OF INACCURACY WAS THE SCREW SKIVING. ADDITIONALLY, IT MAY BE THAT THE TULIP HEAD WASN'T COMPLETELY FIXATED DURING THE INSERTION, LEADING TO A DISCREPANCY BETWEEN THE DISPLAYED VIRTUAL SCREW TRAJECTORY AND THE ACTUAL PEDICLE. BETTER CLARIFICATION REG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734347 ↗
• InjuryJan 18, 2023Use of Device Problem; Use of Device Problem

  XVISION WAS USED ON (B)(6) 2022 (L3-L5 FUSION). THE SURGEON HAD SOME ANATOMICAL ISSUES ON THE PATIENT'S RIGHT AT EACH LEVEL WHERE THE INITIAL TRAJECTORIES WERE MET WITH THE TAP AND DRIVER SKIVING. TRAJECTORIES WERE RESET AND SCREWS WERE PLACED. WHEN EXAMINING THE C-ARM CONFIRMATION IMAGES, THE ALIGNMENT OF THE L3 TRAJECTORIES WAS DIFFERENT, AND NO COMMENTS WERE PROVIDED FOR LL4 AND LL5 WHICH WERE FOUND LATER TOO MEDIAL AND CAUDAL. THE PATIENT DISPLAYED FOOT DROP DUE TO A PINCHED L4 NERVE AND REQUIRED REVISION SURGERY. REVISION SURGERY WAS HELD, AND ALL SCREWS WERE REMOVED. LEFT AND RIGHT L3, RIGHT L4, AND RIGHT L5 HAD SCREWS REPLACED ALONG THE PREVIOUS PATHWAYS. THE SCREWS IN LEFT L4 AND LEFT L5 WERE TOO MEDIAL AND CAUDAL, AND THEIR TRAJECTORIES WERE READJUSTED IN THE REVISION WITHOUT USING THE XVS SPINE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CONTRIBUTING FACTOR TO DEVIATION IN THE TRAJECTORY OF LEFT L4 & LEFT L5 PEDICLE SCREWS IS A COMBINATION OF SOFT TISSUE PRESSURE AND TOOL SKIVING. THE MOST PROBABLE CAUSE FOR THE SCREWS' MISPLACEMENT IS DUE TO TOOL DEVIATION. HOWEVER, THE ROOT CAUSE, IN THIS CASE, CANNOT BE CONCLUDED CONCLUSIVELY. NO SW OR HW MALFUNCTIONS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192663 ↗
• InjuryJan 18, 2023Use of Device Problem; Use of Device Problem

  XVISION WAS USED ON (B)(6) 2022 (L3-L5 FUSION). THE SURGEON HAD SOME ANATOMICAL ISSUES ON THE PATIENT'S RIGHT AT EACH LEVEL WHERE THE INITIAL TRAJECTORIES WERE MET WITH THE TAP AND DRIVER SKIVING. TRAJECTORIES WERE RESET AND SCREWS WERE PLACED. WHEN EXAMINING THE C-ARM CONFIRMATION IMAGES, THE ALIGNMENT OF THE L3 TRAJECTORIES WAS DIFFERENT, AND NO COMMENTS WERE PROVIDED FOR LL4 AND LL5 WHICH WERE FOUND LATER TOO MEDIAL AND CAUDAL. THE PATIENT DISPLAYED FOOT DROP DUE TO A PINCHED L4 NERVE AND REQUIRED REVISION SURGERY. REVISION SURGERY WAS HELD, AND ALL SCREWS WERE REMOVED. LEFT AND RIGHT L3, RIGHT L4, AND RIGHT L5 HAD SCREWS REPLACED ALONG THE PREVIOUS PATHWAYS. THE SCREWS IN LEFT L4 AND LEFT L5 WERE TOO MEDIAL AND CAUDAL, AND THEIR TRAJECTORIES WERE READJUSTED IN THE REVISION WITHOUT USING THE XVS SPINE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CONTRIBUTING FACTOR TO DEVIATION IN THE TRAJECTORY OF LEFT L4 & LEFT L5 PEDICLE SCREWS IS A COMBINATION OF SOFT TISSUE PRESSURE AND TOOL SKIVING. THE MOST PROBABLE CAUSE FOR THE SCREWS' MISPLACEMENT IS DUE TO TOOL DEVIATION. HOWEVER, THE ROOT CAUSE, IN THIS CASE, CANNOT BE CONCLUDED CONCLUSIVELY. NO SW OR HW MALFUNCTIONS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192662 ↗
• InjuryDec 21, 2022Use of Device Problem; Use of Device Problem

  THE SURGEON PLACED FOUR SCREWS UTILIZING THE XVISION SYSTEM. DURING CONFIRMATION OF THE INSTRUMENTATION PROCESS, IT WAS DETERMINED BY THE SURGEON THAT THE LEFT L2 PEDICLE SCREW, WHICH WAS POSITIONED SECOND, WAS MISPLACED (LOW ON THE PEDICLE). THE SURGEON OPTED TO REDIRECT THE SCREW UTILIZING NAVIGATION, HOWEVER, SUBSEQUENT SCANS WERE NOT ABLE TO BE REGISTERED. THUS, THE SURGEON REDIRECTED THE SCREW USING TRADITIONAL PERCUTANEOUS FREEHAND TECHNIQUES. UPON REVIEWING ALL SYSTEM LOGS AND CLINICAL DATA, IT WAS DETERMINED THAT THE MOST LIKELY CONTRIBUTING FACTOR IN THE MISPLACED LEFT L2 PEDICLE SCREW, IS A DEVIATION OF THE TOOL AT THE ENTRY POINT - COMMONLY DESCRIBED AS TOOL SKIVING. TOOL SKIVING OCCURS WHEN THE ENTRY POINT TOPOGRAPHY AND PLANNED TRAJECTORY ANGULATION DO NOT INTERSECT AT A PERENDICULAR ANGLE (90O IN RELATION TO ONE ANOTHER). THE INVESTIGATION CONCLUDED THAT THE EVENT OCCURRED DUE TO THE TOOL SKIVING, WHICH IS PROBABLY ALSO AFFECTED BY THE PATIENT'S ANATOMY. THERE WAS NO INDICATION OF A SYSTEM (HARDWARE/SOFTWARE) MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020928 ↗
• InjuryDec 21, 2022Use of Device Problem; Use of Device Problem

  THE SURGEON PLACED FOUR SCREWS UTILIZING THE XVISION SYSTEM. DURING CONFIRMATION OF THE INSTRUMENTATION PROCESS, IT WAS DETERMINED BY THE SURGEON THAT THE LEFT L2 PEDICLE SCREW, WHICH WAS POSITIONED SECOND, WAS MISPLACED (LOW ON THE PEDICLE). THE SURGEON OPTED TO REDIRECT THE SCREW UTILIZING NAVIGATION, HOWEVER, SUBSEQUENT SCANS WERE NOT ABLE TO BE REGISTERED. THUS, THE SURGEON REDIRECTED THE SCREW USING TRADITIONAL PERCUTANEOUS FREEHAND TECHNIQUES. UPON REVIEWING ALL SYSTEM LOGS AND CLINICAL DATA, IT WAS DETERMINED THAT THE MOST LIKELY CONTRIBUTING FACTOR IN THE MISPLACED LEFT L2 PEDICLE SCREW, IS A DEVIATION OF THE TOOL AT THE ENTRY POINT - COMMONLY DESCRIBED AS TOOL SKIVING. TOOL SKIVING OCCURS WHEN THE ENTRY POINT TOPOGRAPHY AND PLANNED TRAJECTORY ANGULATION DO NOT INTERSECT AT A PERPENDICULAR ANGLE (90O IN RELATION TO ONE ANOTHER). THE INVESTIGATION CONCLUDED THAT THE EVENT OCCURRED DUE TO THE TOOL SKIVING, WHICH IS PROBABLY ALSO AFFECTED BY THE PATIENT'S ANATOMY. THERE WAS NO INDICATION OF A SYSTEM (HARDWARE/SOFTWARE) MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020927 ↗
• InjuryNov 29, 2022Use of Device Problem; Use of Device Problem

  A REVISION CASE WAS DONE WITH A PLAN TO REMOVE 4 SCREWS FROM THE PREVIOUS FUSION AND THEN PLACE 8 SCREWS WITH NAVIGATION. BEFORE X-LINK WAS COMPLETED, PA STARTED USING SUCTION TO CLEAR BLOOD. REP ADVISED HER TO STOP AS ANY PRESSURE COULD ALTER X-LINK ORIENTATION AND RENDER NAVIGATION INACCURATE. PA STOPPED USING SUCTION. AT THIS POINT, THE SURGEON ATTEMPTED TO REMOVE X-LINK AS HE THOUGHT THE X- LINK WAS COMPLETED WHILE HE WAS SCRUBBING IN. REP STOPPED HIM AND X-LINK WAS COMPLETED WITH RESPIRATION HELD. THE REP SUGGESTED RE-SPIN BUT THE SURGEON ELECTED TO CONTINUE WITH THE PROCEDURE. THE REP SUGGESTED THAT THE SURGEON PERFORM A THOROUGH LANDMARK CHECK AND IF ANY INCONSISTENCIES WERE PRESENT, HE SHOULD RE-SPIN. THE SURGEON COMPLETED A LANDMARK CHECK, AND HE DEEMED THE NAVIGATION TO BE ACCURATE. AFTER PLACING THE LL3 SCREW, THE PA BEGIN PLACING THE RL3 SCREW AND STATED IT DIDN'T FEEL RIGHT. THE PA REMOVED THE RL3 SCREW SINCE THE DEPTH OF THE INSTRUMENT SEEMED TO BE "OFF" ON THE NAVIGATION. AT THIS POINT, THE SURGEON ELECTED TO RE-SPIN. BEFORE RE-SPINNING, HE REQUESTED NEUROMONITORING TO STIM THE LL3 SCREW AND IT STIMMED AT 17. UPON RE-SPINNING, HE DEEMED THE LL3 SCREW TO BE MEDIAL AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875826 ↗
• InjuryNov 29, 2022Use of Device Problem; Use of Device Problem

  A REVISION CASE WAS DONE WITH A PLAN TO REMOVE 4 SCREWS FROM THE PREVIOUS FUSION AND THEN PLACE 8 SCREWS WITH NAVIGATION. BEFORE X-LINK WAS COMPLETED, PA STARTED USING SUCTION TO CLEAR BLOOD. REP ADVISED HER TO STOP AS ANY PRESSURE COULD ALTER X-LINK ORIENTATION AND RENDER NAVIGATION INACCURATE. PA STOPPED USING SUCTION. AT THIS POINT, THE SURGEON ATTEMPTED TO REMOVE X-LINK AS HE THOUGHT THE X- LINK WAS COMPLETED WHILE HE WAS SCRUBBING IN. REP STOPPED HIM AND X-LINK WAS COMPLETED WITH RESPIRATION HELD. THE REP SUGGESTED RE-SPIN BUT THE SURGEON ELECTED TO CONTINUE WITH THE PROCEDURE. THE REP SUGGESTED THAT THE SURGEON PERFORM A THOROUGH LANDMARK CHECK AND IF ANY INCONSISTENCIES WERE PRESENT, HE SHOULD RE-SPIN. THE SURGEON COMPLETED A LANDMARK CHECK, AND HE DEEMED THE NAVIGATION TO BE ACCURATE. AFTER PLACING THE LL3 SCREW, THE PA BEGIN PLACING THE RL3 SCREW AND STATED IT DIDN'T FEEL RIGHT. THE PA REMOVED THE RL3 SCREW SINCE THE DEPTH OF THE INSTRUMENT SEEMED TO BE "OFF" ON THE NAVIGATION. AT THIS POINT, THE SURGEON ELECTED TO RE-SPIN. BEFORE RE-SPINNING, HE REQUESTED NEUROMONITORING TO STIM THE LL3 SCREW AND IT STIMMED AT 17. UPON RE-SPINNING, HE DEEMED THE LL3 SCREW TO BE MEDIAL AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875821 ↗
• InjuryJan 16, 2022Use of Device Problem; Use of Device Problem

  DURING T7-T11 FUSION PROCEDURE, STRAIGHT CLAMP WAS POSITIONED ON THE SPINOUS PROCESS OF T7. FOLLOWING SUCCESSFUL REGISTRATION, LANDMARK CHECK WAS PERFORMED BY THE SURGEON TO AFFIRM ACCURATE REGISTRATION. DRILL WAS USED FOR PILOT HOLES STARTING FROM PATIENT LEFT T7 DOWN TO LEFT T11 FOLLOWED BY TAP IN THE SAME DIRECTION. TRAJECTORIES WERE PLACED FOR PATHWAY OF EACH SCREW WITH SOME TRAJECTORIES REPLACED DUE TO DIFFICULTY WITH TRANSVERSE PROCESSES. SCREWS WERE PLACED FROM LEFT T11 UP TO LEFT T7. WHEN MOVING TO INSTRUMENT RIGHT T7, THE SURGEON PERFORMED ADDITIONAL LANDMARK CHECK WITH TAP AND DRILL ON THE ANATOMY AS WELL AS ON THE SCREWS ON THE LEFT SIDE. LANDMARK CHECK ON THE SCREWS ON THE LEFT SIDE CONSTRUCT SHOWED INSTRUMENT WAS LATERAL IN NAVIGATION IN COMPARISON TO THE PLACEMENT OF INSTRUMENT IN CONSTRUCT. DRILL AND TAP WERE RECALIBRATED. INACCURACY REMAINED WITH ANOTHER LANDMARK CHECK AFTER RECALIBRATION. THE SURGEON DECIDED TO CONTINUE WITH INSTRUMENTATION ON THE RIGHT SIDE USING THE FREE HAND TECHNIQUE. POST-OP SCAN DEMONSTRATED THAT LEFT T7 SCREW, THAT WAS POSITIONED WITH THE NAVIGATION SYSTEM, AND THE RIGHT T8 & T10 SCREWS, THAT WERE POSITIONED BY FREE HAND, WERE TOO LATERAL. S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262613 ↗