n/a 8350322Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00613994282743), received between Oct 23, 2018 and Jan 3, 2024 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN OBTURATOR USED ON A PATIENT HAVING POSTERIOR CORRECTION AND FIXATION THERAPY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). IT WAS REPORTED THAT DURING THE REMOVAL OF THE RP2 SETSCREW (AFTER THREADING), THE OBTURATOR T25 WAS USED WITH A SETSCREW BREAK-OFF SCREWDRIVER. WHEN THE OBTURATOR WAS TURNED (CLOCKWISE) IN THE DIRECTION OF TIGHTENING, WHICH IS THE WRONG DIRECTION FOR REMOVAL, THE TIP OF THE T25 OBTURATOR WAS BROKEN. THE PRODUCT WAS NOT USED CORRECTLY AS PER THE INSTRUCTIONS IN THE PROCEDURE MANUAL. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WAS NO REVISION SURGERY PLANNED AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434597 ↗
• MalfunctionAug 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN REVISION SURGERY TO REMOVE THE HARDWARE FOR STENOSIS. IT WAS REPORTED THAT TIPS OF THE DEVICES WERE BROKEN WHEN ATTEMPTING TO MOVE OLD HARDWARE. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478807 ↗
• MalfunctionApr 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING REVISION SURGERY FOR ROD BREAKAGE AND LOOSENING OF THE TRANSLACE AT (B)(6) 2012. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN DURING REMOVAL OF THE TRANSLACE. THE FRAGMENTS WERE COLLECTED AND NOT LEFT INSIDE THE BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759105 ↗
• MalfunctionApr 18, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF T10-T12 WITH A REVISION PLF T6-L4 FOR DEGENERATIVE DISC DISEASE T10-T12. IT WAS REPORTED THAT THE TIP OF THE OBTURATOR BENT AND BROKE OFF WHILE TRYING TO REMOVE A SET SCREW, THE BROKEN TIP WAS RETRIEVED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759023 ↗
• MalfunctionMar 14, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REDO L5-S1 FORA MINOTOMY AND POSTEROLATERAL ONLAY FUSION, OPEN SACROILIAC JOINT ARTHRODESIS, AND REVISION OF PRIOR INSTRUMENTATION. IT WAS REPORTED THAT THE DRIVERS BROKE. THE TIP OF THE INSTRUMENT (OBTURATOR) BROKE. NO FRAGMENTS WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. REVISION WAS NOT A RESULT OF USING MEDTRONIC HARDWARE. THE BROKEN DRIVERSWERE A RESULT OF FRICTION WITHIN THE PEDICLE. THE SCREW NO LONGER MOVED FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535431 ↗
• MalfunctionMar 6, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPI NAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF OBTURATOR WAS BENT AND BROKE, RESULTING IN USE OF DIFFERENT DRIVER FOR REMOVAL OF IMPLANTS. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485203 ↗
• MalfunctionJan 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING GROWING ROD EXTENSION SURGERY. IT WAS REPORTED THAT THE T25 SHAFT TIP WAS BROKE DURING INITIAL SURGERY ON (B)(6) 2020 AND TIP WAS STUCK ON THE SET SCREW ON THE MRC. THIS TIP WAS REMOVED IN THE CURRENT SURGERY WHICH WAS BEING PERFORMED FOR GROWING ROD EXTENSION. NO INSTRUMENT DEBRIS WAS LEFT IN THE PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16081789 ↗
• MalfunctionDec 20, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L3/4/5 INTERSPINAL STENOSIS. IT WAS REPORTED THAT AFTER THE L3/4 XLIF, A ROD WAS FIXED ON THE L3/4, HOWEVER, THE FIXED ROD WAS REMOVED IN ORDER TO DEEPLY INSERT THE SCREW. THERE WERE NO PROBLEMS WITH THE USAGE OF THE INSTRUMENTS, BUT THE FRONT END OF THE OBTURATOR BROKE WHEN THE OBTURATOR WAS TURNED COUNTER-CLOCKWISE IN ORDER TO REMOVE THE PLUG. THE TIP OF THE BROKEN OBTURATOR WAS BURIED IN THE HOLE OF THE PLUG, SO IT WAS DECIDED TO BE TAKEN OUT. THE OBTURATOR DEBRIS REMAINING IN THE THREADED BREAK OFFSET SCREW WAS REMOVED. THE SAME EVENT OCCURRED WITH THE DRIVER. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINS. BONE FUSION WAS NOT PERFORMED IMMEDIATELY AFTER THE OPERATION BUT THE PATIENT RECOVERED. XLIF OF L3/4/5 +L 3/4 FRONT,1 ROD FIXED (LEGACY ANTALES) WAS SCHEDULED. THE PROCEDURE WAS XLIF FOR L3/4, FOLLOWED BY ANTALES FOR L3/4. THE ANCHORING WAS PERFORMED UNTIL THE FINAL ANCHORING OF THE ANTALES, BUT THE SCREWDRIVER WAS BROKEN WHEN THE PLUG WAS REMOVED TO REMOVE THE ROD IN ORDER TO ADJUST THE SCREW DEPTH. THE DRIVER WAS ASSOCIATED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16012396 ↗
• MalfunctionDec 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN REINSTALLATION OF ROD. IT WAS REPORTED THAT THE OBTURATOR TIP BROKE OFF DURING ATTEMPTED REMOVAL DUE TO CROSS-THREADED MRC SET SCREW. LEVEL AT WHICH THE IMPLANT WAS PERFORMED WAS TH10-L5. THIS WAS A REPEAT SURGERY AND THE REASON FOR REPEAT SURGERY WAS RE-ANCHORING THIS TIME DUE TO ROD FRACTURE. THE TYPE OF THE INITIAL SURGERY WAS THORACOLUMBAR POSTERIOR FUSION. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS ROD FRACTURE. NO DELAY IN THE OVERALL PROCEDURE TIME. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE BROKEN ROD WAS CONNECTED AND FIXED AT THE BROKEN PART USING AXIAL DOMINOES. ONE ROD WAS ADDED USING A CONNECTOR FOR REINFORCEMENT. THE SET SCREW OF THE CONNECTOR WAS CROSS-THREADED BUT WAS LEFT IN PLACE (IN CONTINUOUS USE) BASED ON THE PHYSICIAN'S JUDGMENT THAT IT WAS FIRMLY FIXED. IT HAS BEEN CONFIRMED THAT THE BROKEN PIECE OF THE SCREWDRIVER HAS BEEN REMOVED. DISEASE AT INITIAL SURGERY: PARKINS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003422 ↗
• MalfunctionOct 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN LUMBAR F USION SPINAL SURGERY FOR SPINAL STENOSIS. IT WAS REPORTED THAT THE BENDER WAS BROKEN. WHEN REMOVING EXISTING SET SCREWS, THE TIP OF THE OBTURATOR BROKE OFF. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15648262 ↗
• MalfunctionSep 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SPINAL DEVICES USED IN SPINAL FUSION. IT WAS REPORTED THAT THE SET SCREW WAS IDLING WHEN THE FINAL WAS PERFORMED WITHOUT THE COUNTER. AFTERWARDS, THE FINAL WAS PERFORMED, BUT IT SEEMED LIKE THE SET SCREW WAS DIAGONAL, SO THE SET SCREW WAS REPLACED AND THE FINAL WAS PERFORMED AGAIN, BUT IT WAS IDLING AGAIN. THE SAME PROCEDURE WAS REPEATED TWICE, AND 2 SCREWS WERE ALSO REPLACED. IT WAS ALSO REPORTED THAT, WHEN REMOVING THE SET SCREW, IT WAS HARDER THAN USUAL AND THE 2 OBTURATORS WERE BROKEN, SO IT WOULD BE RETURNED. THERE WAS A DELAY OF GREATER THAN 60 MINUTES IN THE OVERALL PROCEDURE. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS SCOLIOSIS. LEVEL AT WHICH IMPLANT WAS PERFORMED- T11-L3. THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT BODY AND NO SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SECOND SCREW COULD NOT BE TIGHTENED AND REPLACED, SETSCREW IDLED AND REPLACED, AND THE OBTURATORS WERE BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410778 ↗
• MalfunctionSep 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SPINAL DEVICES USED IN SPINAL FUSION. IT WAS REPORTED THAT THE SET SCREW WAS IDLING WHEN THE FINAL WAS PERFORMED WITHOUT THE COUNTER. AFTERWARDS, THE FINAL WAS PERFORMED, BUT IT SEEMED LIKE THE SET SCREW WAS DIAGONAL, SO THE SET SCREW WAS REPLACED AND THE FINAL WAS PERFORMED AGAIN, BUT IT WAS IDLING AGAIN. THE SAME PROCEDURE WAS REPEATED TWICE, AND 2 SCREWS WERE ALSO REPLACED. IT WAS ALSO REPORTED THAT, WHEN REMOVING THE SET SCREW, IT WAS HARDER THAN USUAL AND THE 2 OBTURATORS WERE BROKEN, SO IT WOULD BE RETURNED. THERE WAS A DELAY OF GREATER THAN 60 MINUTES IN THE OVERALL PROCEDURE. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS SCOLIOSIS. LEVEL AT WHICH IMPLANT WAS PERFORMED- T11-L3. THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT BODY AND NO SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SECOND SCREW COULD NOT BE TIGHTENED AND REPLACED, SETSCREW IDLED AND REPLACED, AND THE OBTURATORS WERE BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410765 ↗
• MalfunctionJun 21, 2022Material Twisted/Bent; Material Twisted/Bent

  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 SHAFT WERE DAMAGED (BENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751367 ↗
• MalfunctionJun 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF SCOLIOSIS GROWTH RODS/SCOLIOSIS WITH SOLERA 4.75 SYSTEM DUE TO SCOLIOSIS. IT WAS REPORTED THAT THE SETSCREWS WAS EXTREMELY HARD TO REMOVE, HENCE THE BREAKING OF THE DRIVERS.  THERE WAS NO PATIENT SYMPTOM REPORTED. THE SURGERY WAS DELAYED TO GET EXTRA DRIVERS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600780 ↗
• MalfunctionMay 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR DDD REVISION DUE TO INFECTION. IT WAS REPORTED THAT THE END OF THE INSTRUMENTS BROKE DUE TO THE SET SCREWS BEING TOO TIGHT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14392871 ↗
• MalfunctionApr 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT UNKNOWN SPINAL THERAPY FOR IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE R2 BREAK-OFF SET SCREW, THE T25 OBTURATOR WAS BROKEN. THE COUNTER WAS USED, BUT THE TIP OF THE DEVICE REMAINED INSIDE THE SET SCREW WITH THE SCREW BROKEN OFF. SUCTION WAS USED AND THE REMAINING PARTS WERE REMOVED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBER OF THE REPORTED PRODUCT IS (B)(4). THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110322 ↗
• MalfunctionMar 9, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED IN S5 TR. THIS PROCEDURE WAS A REVISION SURGERY FOR SUSPECTED INFECTION .INITIAL SURGERY: (B)(6) 2018 . IT WAS REPORTED THAT WHEN REMOVING THE SET SCREW OF THE TR CONNECTOR PLACED ON THE RIGHT SIDE OF L3, THE TIP OF THE REPORTED PRODUCT WAS DAMAGED. THE PRODUCT OF THE  SAME TYPE SHIPPED FOR BACKUP WAS USED TO ATTEMPT REMOVAL, BUT THE TIP WAS DEFORMED. REMOVAL OF THE SET SCREW WAS DISCONTINUED,  AND THE ROD AND THE SET SCREW WERE REMOVED IN ONE MASS, THEN THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. 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 13706508 ↗
• MalfunctionMar 9, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED IN S5 TR. THIS PROCEDURE WAS A REVISION SURGERY FOR SUSPECTED INFECTION .INITIAL SURGERY: (B)(6) 2018. IT WAS REPORTED THAT WHEN REMOVING THE SET SCREW OF THE TR CONNECTOR PLACED ON THE RIGHT SIDE OF L3, THE TIP OF THE REPORTED PRODUCT WAS DAMAGED. THE PRODUCT OF THE  SAME TYPE SHIPPED FOR BACKUP WAS USED TO ATTEMPT REMOVAL, BUT THE TIP WAS DEFORMED. REMOVAL OF THE SET SCREW WAS DISCONTINUED,  AND THE ROD AND THE SET SCREW WERE REMOVED IN ONE MASS, THEN THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. 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 13706228 ↗
• MalfunctionMar 7, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING REMOVAL OF HARDWARE THE T25 OBTURATOR TIP BECAME TWISTED MAKING IT NOT USEABLE. 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 13682457 ↗
• MalfunctionFeb 15, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN OBTURATOR IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE TIP OF INSTRUMENT TWISTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13531458 ↗
• 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 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13329898 ↗
• 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 13150590 ↗
• MalfunctionJan 3, 2022Material Twisted/Bent; Material Twisted/Bent

  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 PRODUCT BROKE. LATER, OBTURATOR WAS USED TO REMOVE THE SCREW BUT THE TIP OF OBTURATOR BENT. THERE WAS A DELAY OF LESS THAN 60MINUTES REPORTED AS A RESULT OF BOTH THE PRODUCTS MALFUNCTION. 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 13140412 ↗
• MalfunctionDec 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A OBTURATOR USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS SPINAL STENOSIS. PROCEDURE PERFORMED WAS TLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE TIP OF THE DRIVER SHEARED OFF. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS A SHORT DELAY BUT THERE ARE MULTIPLE OF THE INSTRUMENTS IN THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012194 ↗
• MalfunctionAug 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR DEGEN ERATIVE LOW BACK PAIN WITH A LUMBAR FUSION L2-L5. IT WAS REPORTED THAT TIP OF THE OBTURATOR BROKE OFF WHEN SURGEON REMOVED ONE OF THE SET SCREWS IN THE REVISION OF A SCREW FROM THE EXISTING CONSTRUCT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO BROKEN FRAGMENTS OF DRIVER LEFT INSIDE THE PATIENT. PROCEDURE INVOLVED WAS LUMBAR POSTERIOR FUSION WITH REVISION OF THE SCREW AND ROD CONSTRUCT. LEVELS IMPLANTED WAS 4 LEVELS IN PRIOR SURGERY AND IN THE SURGERY WITH THE BROKEN SCREW DRIVER JUST 2 SCREWS REVISED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT AND NO INJURY DUE THE BROKEN SCREWDRIVER. THERE IS NO MALFUNCTION OF THE SCREWS AND CAUSE OF LOOSENING IS DUE TO OSTEOPOROTIC BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12265273 ↗