N/A 815-518Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00673978045092), received between Jul 30, 2018 and Jun 25, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE SCREW DRIVER WAS FOUND BROKEN PRIOR TO A SPINE PROCEDURE. THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326539 ↗
• MalfunctionJan 3, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A REVISION OF HARDWARE. IT WAS REPORTED THAT TIP BROKE OFF WHILE TRYING TO REMOVE THE SCREW. NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435297 ↗
• MalfunctionNov 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4-S1 PLIF PROCEDURE. IT WAS REPORTED THAT THE TIP OF SCREWDRIVER BROKE OFF WHILE SURGEON WAS ATTEMPTING TO TIGHTEN SET SCREW. TIP BROKE OFF INTO SET SCREW, SURGEON WAS ABLE TO RETRIEVE AND REMOVE FROM SURGICAL SITE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211119 ↗
• MalfunctionJun 6, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR REVISION FOR AN INDICATION OF DEGENERATIVE DISK DISEASE. IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF WHILE REMOVING THE SCREW. THE SCREW WAS REVISED AND THERE WAS NO MALFUNCTION WITH THE SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068220 ↗
• MalfunctionApr 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING EXTREME LATERAL INTERBODY FUSION (XLIF) FOR DISC HERNIATION. IT WAS REPORTED THAT WHILE REMOVING SCREW THAT HAD BEEN IMPLANTED, TIP OF DRIVERS WERE BROKE OFF. FRAGMENTS WERE REMOVED FROM PATIENT. LEVELS IMPLANTED WERE T10-P. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761215 ↗
• MalfunctionMar 7, 2023Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 PLIF FOR AN INDICATION OF LCS. IT WAS REPORTED THAT DURING THE FINAL FASTENING, THE TIP OF SHAFT T25 BROKE OFF, AND THE BROKEN PIECE REMAINED IN THE CENTER OF THE SET SCREW. IT WAS TRIED TO REMOVE THE BROKEN PIECE USING SUCTION, BONE WAX, ETC. BUT NOTHING COULD REMOVE THEM, SO THE DOCTOR DECIDED TO LEAVE IT INSIDE THE BODY. USING A SPARE SHAFT T25 (815-518), THE FINAL FASTENING AT THE SECOND LOCATION WAS COMPLETED SUCCESSFULLY, BUT THE TIP OF THE SHAFT T25 (815-518) BROKE OFF AGAIN AT THE THIRD LOCATION. LIKEWISE, THE PIECE COULD NOT BE REMOVED AND WAS LEFT INSIDE THE BODY. THE TIP OF THE ANOTHER SPARE T25 SHAFT IS CHIPPED AND DEFORMED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493578 ↗
• MalfunctionMar 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 PLIF FOR AN INDICATION OF LCS. IT WAS REPORTED THAT DURING THE FINAL FASTENING, THE TIP OF SHAFT T25 BROKE OFF, AND THE BROKEN PIECE REMAINED IN THE CENTER OF THE SET SCREW. IT WAS TRIED TO REMOVE THE BROKEN PIECE USING SUCTION, BONE WAX, ETC. BUT NOTHING COULD REMOVE THEM, SO THE DOCTOR DECIDED TO LEAVE IT INSIDE THE BODY. USING A SPARE SHAFT T25 (815-518), THE FINAL FASTENING AT THE SECOND LOCATION WAS COMPLETED SUCCESSFULLY, BUT THE TIP OF THE SHAFT T25 (815-518) BROKE OFF AGAIN AT THE THIRD LOCATION. LIKEWISE, THE PIECE COULD NOT BE REMOVED AND WAS LEFT INSIDE THE BODY. THE TIP OF THE ANOTHER SPARE T25 SHAFT IS CHIPPED AND DEFORMED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16493560 ↗
• MalfunctionMar 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 PLIF FOR AN INDICATION OF LCS. IT WAS REPORTED THAT DURING THE FINAL FASTENING, THE TIP OF SHAFT T25 BROKE OFF, AND THE BROKEN PIECE REMAINED IN THE CENTER OF THE SET SCREW. IT WAS TRIED TO REMOVE THE BROKEN PIECE USING SUCTION, BONE WAX, ETC. BUT NOTHING COULD REMOVE THEM, SO THE DOCTOR DECIDED TO LEAVE IT INSIDE THE BODY. USING A SPARE SHAFT T25 (815-518), THE FINAL FASTENING AT THE SECOND LOCATION WAS COMPLETED SUCCESSFULLY, BUT THE TIP OF THE SHAFT T25 (815-518) BROKE OFF AGAIN AT THE THIRD LOCATION. LIKEWISE, THE PIECE COULD NOT BE REMOVED AND WAS LEFT INSIDE THE BODY. THE TIP OF THE ANOTHER SPARE T25 SHAFT IS CHIPPED AND DEFORMED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16493542 ↗
• MalfunctionDec 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FUSION (PF) FOR CERVICAL THORACIC METASTATIC MALIGNANCY. LEVEL AT WHICH IMPLANT WAS PERFORMED: C4 TO TH4 IT WAS REPORTED THAT THE TIP OF SHAFT T25 WAS BROKEN DURING THE FINAL TIGHTENING OF THE NON-BREAK SET SCREW USING THE REPORTED PRODUCTS. THE BROKEN TIP WAS STUCK IN THE SET SCREW, MAKING EXTRACTION DIFFICULT. THEREFORE, IT WAS RETAINED INSIDE THE BODY AT THE DISCRETION OF THE PHYSICIAN. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15903000 ↗
• MalfunctionNov 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-4 OF 2 INTER VERTEBRAL OLIF FOR AN INDICATION OF LCS. IT WAS REPORTED THAT THE SHAFT TIP WAS BROKEN AT THE TIME OF THE L4 LEFT FINAL FASTENING AND IT WAS COMPLETELY BURIED IN THE SET SCREW AND COULD NOT BE REMOVED. WITH THE PHYSICIAN'S JUDGMENT, THE LEFT L4 WAS CLOSED AS IT IS, AND THE REMAINING SCREW WAS TIGHTENED WITH A SPARE SHAFT. THERE WAS A DELAY OF LESS THAN60 MINS REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15795463 ↗
• MalfunctionAug 3, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T7-S1 REVISION POSTERIOR SPINAL FUSION LUMBAR AND THORACIC AND T8-PELVIS SURGERY. IT WAS REPORTED THAT THE SHAFT WAS USED TO REMOVE A SCREW AND THE HEAD OF IT BENT SLIGHTLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161775 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION/ HARDWARE REMOVAL FOR SPONDYLOLISTHESIS AND DISC DEGENERATIVE DISEASE. IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A HARDWARE REMOVAL WHICH CAN BE DIFFICULT/COMPLICATED. UNFORTUNATELY, MULTIPLE INSTRUMENTS WERE DAMAGED/BROKEN IN THE PROCESS. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE: ALL THE INSTRUMENTS IN THE REPORT CAME IN CONTACT WITH THE PATIENT. THE PRODUCTS: PROBE, OBTURATOR, TORX 20 SHAFT WERE DAMAGED (BENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751422 ↗
• MalfunctionMay 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING DRIVERS USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS LUMBAR SPINAL CANAL STENOSIS. PROCEDURE PERFORMED WAS 1 INTERVERTEBRAL TLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, WITH T25 SHAFT AND TORQUE LIMITING HANDLE DURING THE FINAL TIGHTENING, THE TORQUE WAS TOO HARD, AND IT SEEMS THAT THE SHAFT TIP WAS BROKEN. IT WAS POINTED OUT THAT THE TORQUE VALUE OF THE TORQUE LIMITING HANDLE WAS TOO HARD COMPARED BEFORE. THE TIP OF THE SCREWDRIVER BROKE OFF DURING THE FINAL TIGHTENING OF THE NON-BREAK SET SCREW OF SOLERA475. IT WAS BROKEN AT THE FINAL TIGHTENING OF THE FIRST OR SECOND ONE. COUNTER-TORQUE WAS USED AT THE SAME TIME. ONLY ONE OF THE TWO DRIVERS WERE BROKEN. THE PHYSICIAN CONCLUDED THAT THE TORQUE VALUE FELT HIGH, AND AFTER THE DRIVER WAS BROKEN, THE TORQUE LIMITING HANDLE WAS NOT USED, AND THE MANUAL FINAL TIGHTENING WAS DONE MANUALLY. THE TORQUE LIMITING DRIVER CONTRIBUTED TO THE BREAKAGE OF THE SHAFT. IT WAS ALLEGED THAT THE TORQUE VALUE OF THE TORQUE LIMITING DRIVER INSTRUMENT WAS TOO STIFF. THE PRODUCTS CAME IN CONTACT WITH PATIENT. THERE WAS APPROXIMATELY ONE MINUTE DELAY. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470645 ↗
• MalfunctionJan 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED FOR WITH SPINAL SURGERY. PRE-OP DIAGNOSIS WAS ROD BREAKAGE. PROCEDURE PERFORMED WAS CUT THE BAR OF GX7041430 WITH THE AIR TOME AND REMOVED IT. IT WAS REPORTED THAT INTRA-OPERATIVELY, DRIVERS WERE USED TO REMOVE THE GX7049855, BUT THE TIP BROKE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WAS A DELAY OF LESS THAN 60 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13329896 ↗
• MalfunctionJan 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS DEGENERATIVE DISC DISEASE, HARDWARE REVISION. THE PROCEDURE OR TECHNIQUE WAS LUMBAR FUSION HARDWARE REMOVAL. IT WAS REPORTED THAT, THE PRODUCTS WERE BROKEN DURING REVISION SURGERY. THERE WERE NO FRAGMENTS OF BROKEN INSTRUMENTS REMAINS IN PATIENT. THE REVISION SURGERY WAS PERFORMED DUE TO ADJACENT LEVEL FAILURE. THERE WAS NO MALFUNCTION OF PRODUCTS USED IN INITIAL SURGERY LEAD TO THIS REVISION. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS  A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150549 ↗
• MalfunctionJan 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS CONGENITAL SCOLIOSIS. THE PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR FUSION. IT WAS REPORTED THAT, WHEN AN ATTEMPT WAS MADE TO LOOSEN THE MRC SET SCREW USED DURING THE LAST TIME OPERATION, THE TIP OF THE REPORTED TORX SHAFT WAS BROKEN. LATER, OBTURATOR WAS USED TO REMOVE THE SCREW BUT THE TIP OF OBTURATOR BENT. THE REPORTED EVENT WAS HAPPENED DURING REVISION SURGERY. IT IS A TWO STAGE SURGERY FOR CONGENITAL SCOLIOSIS. LAST TIME IT WAS L3-5 POSTERIOR FUSION, THIS TIME POSTERIOR FUSION AT T3-T12 AND ROD CONNECT WERE PERFORMED. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WERE NO BROKEN FRAGMENTS OF INSTRUMENT REMAINS IN PATIENT. THE LEVELS IMPLANTED WERE T3-T12. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13140358 ↗
• MalfunctionDec 20, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED, FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE. REGARDING AN EVENT HAPPENED, DURING INTRA-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED, THAT THE TIP OF SHAFT WAS BENT, WHILE TRYING TO REMOVE A PEDICLE SCREW. THE SCREWDRIVER TIP SHEARED OFF. THERE WAS NO BROKEN FRAGMENT LEFT IN THE PATIENT BODY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR FUSION. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042097 ↗
• MalfunctionDec 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SET SCREWS AND POLYAXIAL SCREWS USING DRIVERS IN A REVISION POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT DURING THE EXPLANTATION OF A PREVIOUSLY IMPLANTED NON-MDT CONSTRUCT, MULTIPLE DRIVERS TIPS WERE BROKEN AT DIFFERENT TIMES WHILE ATTEMPTING TO REMOVE THE SET SCREWS AND POLY AXIAL SCREWS. THE BROKEN TIPS WERE ALL IDENTIFIED AND DISCARDED. POST-OPERATIVE IMAGING CONFIRMED THAT THERE WERE NO METAL FRAGMENTS REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF PROBABLY 10 MINUTES IN OVERALL PROCEDURE TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914738 ↗
• MalfunctionNov 24, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR PSEUDOARTHROSIS. PROCEDURE OR TECHNIQUE USED WAS REMOVAL - EXPLORATION OF FUSION. IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF WHILE BACKING A SCREW OUT OF PATIENT. DRIVER FRAGMENT WAS RETRIEVED AND DISCARDED THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866945 ↗
• MalfunctionOct 1, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL FRACTURE DISLOCATION. LEVELS IMPLANTED T6-S1. IT WAS REPORTED THAT THE INSTRUMENT WAS BEING USED TO REMOVE INSTRUMENTATION FROM A PREVIOUS FUSION THAT HAD TO BE REMOVED PRIOR TO TREATING THE FRACTURE DISLOCATION. DURING THE REMOVAL OF INSTRUMENTATION FROM A PREVIOUS SURGERY, BOTH OF THESE INSTRUMENTS WERE USED TO REMOVE THE MULTIRACIAL SCREWS. DURING THE REMOVAL PROCESS THE TIPS OF THE INSTRUMENTS BROKE OFF. THE TIPS WERE LOCATED AND REMOVED FROM THE PATIENT. ADDITIONALLY, POST-OP X-RAYS WERE USED TO CONFIRM THAT THERE WERE NO REMAINING FRAGMENTS LEFT IN THE PATIENT. THIS ADDED TIME AND INCONVENIENCE TO THE CASE AS IT MADE THE REMOVAL OF THE INSTRUMENTATION MORE TAXING AND TIME WAS LOST LOCATING THE BROKEN TIPS. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE CUMULATIVE OVER DELAY OF ALL INSTRUMENT FAILURES TO BE 15 MINUTES. THE PROCEDURE WAS A POSTERIOR SPINAL FUSION USED TO TREAT A FRACTURE DISLOCATION INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12559027 ↗
• MalfunctionMay 25, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FAILED FUSION AT L3-4 FOR REVISION/REMOVAL HARDWARE L3-S1, NEW L3-4 FUSION THERAPY. IT WAS REPORTED THAT DURING REMOVAL OF SET SCREW FOR L4 SCREW THE TIP OF THE T25 DRIVER SNAPPED INSIDE THE SET SCREW. IT WAS SUBSEQUENTLY REMOVED WHEN THE PREVIOUS HARDWARE WAS REMOVED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT PATIENT NEEDED A RE-OPERATION BECAUSE HER HARDWARE WAS LOOSE BECAUSE OF A NON-UNION. SHE DIDN'T FUSE, SO THE HARDWARE BECAME LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874888 ↗
• MalfunctionMay 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF VERTEBRAL CANAL STENOSIS AT L5/S IN NEED OF L5/S TLIF USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN RETIGHTENING SET SCREW WITH A DRIVER THAT COMBINED THE 815-518 SHAFT T25 AND THE 8880009 SO47 TORQUE LIMITING DRIVER, THE TIP OF THE BROKE DURING RETIGHTENING OF THE NON-BREAK SET SCREW OF SOLERA 4.75. THE BROKEN TIP WAS REMOVED FROM THE SURGICAL FIELD. THE EVENT WAS THOUGHT TO HAVE OCCURRED IN THE 4TH ONE OF FIXATION OF ONE INTERVERTEBRAL DISC. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789009 ↗
• MalfunctionMay 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED OF T12-PELVIS, POSTERIOR THORACOLUMBAR REVISION USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHILE TRYING TO TAKE OUT OLD HARDWARE, THE BONE WAS SCLEROTIC AND DIFFICULT TO REMOVE THE SCREWS WHICH LEAD TO THE BREAKAGE OF BOTH OF THESE T20 AND T25 DRIVER TIPS. THE SURGEON WAS ABLE TO RETRIEVE BOTH OF THE BROKEN TIPS FROM THE OLD SCREW HEADS. THERE WAS A DELAY OF ABOUT 5 MINS REPORTED. THE REVISION WAS NOT DUE TO MALFUNCTION OF THE OLD HARDWARE AND THE REVISION IS TO REPLACE THE OLD SCREWS WITH NEW AS THE OLD ONES COULD BE LOOSE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758990 ↗
• MalfunctionJan 18, 2021Material Deformation; Material Deformation

  HOLD FOR R.G. 1.20INFORMATION WAS RECEIVED FROM USER FACILITY VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF SPINAL CANAL STENOSIS INVOLVED IN PLIF PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, WHEN THE SET SCREW WAS TIGHTENED, IT IDLED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO ADDITIONAL TREATMENT/SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. EVENT WAS ASSOCIATED WITH THE PATIENT. INITIAL REPORTER INFORMATION IS NOT PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. LEVELS IMPLANTED- L5/S RECEIVED ADDITIONAL INFORMATION THAT WHEN THE SET SCREW FOR THE SOLERA 4.75 REDUCTION SCREW WAS FINALLY TIGHTENED, IT WAS NOT KICKED OFF USING THE REPORTED DRIVER. ANOTHER SAME DRIVER WAS USED AND FINAL TIGHTENING WAS ABLE TO BE PERFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT AS IT WAS USED IN THE WOUND. THERE WERE NO MECHANICAL/FUNCTIONAL ISSUES. THE MALFUNCTION SEEMED TO BE SOME DEFORMATION. THE EXACT MALFUNCTION WAS UNABLE TO BE SEEN CLEARLY DUE TO THE BLOOD STAINS, BUT WHEN IT WAS CHECKED AFTER BEING CLEANED, THERE WAS A CLEAR DEFORMAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184092 ↗
• MalfunctionNov 12, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING DRIVERS FOR A POSTERIOR FUSION AND CORPECTOMY . IT WAS REPORTED THAT THE DRIVER TIPS SHEARED OFF DURING HARDWARE REMOVAL. BROKEN FRAGMENTS WERE RECOVERED AND ALTERNATIVE INSTRUMENTS USED. THE INSTRUMENTS BROKE AND THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THE DRIVER BROKE DURING THE EXTENSION/REVISION SURGERY. WE USED ALTERNATIVE DRIVERS TO REMOVE THE IMPLANTS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CAME IN CONTACT WITH THE INSTRUMENTS. THE PRE-OP DIAGNOSIS WAS EXTENSION/ REVISION OF FUSION. THE LEVELS IMPLANTED WERE T4-T9. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. MEDTRONIC PRODUCTS WERE USED IN THE INITIAL SURGERY AND HAD NO MALFUNCTION THAT RESULTED IN THE REVISION SURGERY. PATIENT SUFFERED SUBSEQUENT INJURY AFTER INITIAL SURGERY AND REQUIRED ADDITIONAL STABILIZATION. THE PRODUCTS WILL BE REPLACED BY MEDTRONIC PRODUCTS IN THE FUTURE. THE PATIENT'S MEDICAL HISTORY INCLUDES OBESITY. NO FURTHER COMPLICATIONS WERE R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10827400 ↗