T-PLIFRecalls & reported problems across all models

We found 11 models of T-PLIF by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2017 and Feb 23, 2024 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported T-PLIF problems

T-PLIF models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• T-PLIF 389.266

  FORCEPS, GENERAL & PLASTIC SURGERY
  8 reports
• T-PLIF 389.274

  IMPACTOR
  4 reports
• T-PLIF 03.806.008

  TEMPLATE
  1 report
• T-PLIF 03.806.010

  TEMPLATE
  1 report
• T-PLIF 03.806.012

  TEMPLATE
  1 report
• T-PLIF 389.267

  TEMPLATE
  1 report
• T-PLIF 389.268

  TEMPLATE
  1 report
• T-PLIF 389.269

  TEMPLATE
  1 report
• T-PLIF 389.272

  TEMPLATE
  1 report
• T-PLIF 389.273

  TEMPLATE
  1 report
• T-PLIF 389.910

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent T-PLIF adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: THE SURGEON WAS INSERTING A TPLIF GRAFT FROM MTF AND ONE OF THE 'ARMS' AT THE PROXIMAL TIP WAS SIGNIFICANTLY BENT. THE NURSE SUBSEQUENTLY ATTEMPTED TO STRAIGHTEN THE ARM AND IT BROKE OFF ON THE BACK TABLE. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE OTHER SET FOUND AT THE HOSPITAL. NOTHING FELL INTO THE PATIENT AND THE PATIENT WAS NOT IMPACTED, THEREFORE NO PATIENT DETAILS WERE OBTAINED. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT INTERVENTIONAL. NO FRAGMENTS FELL INTO THE PATIENT AND THE PIECE WAS THROWN AWAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770334 ↗
• MalfunctionMar 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DEPARTMENT HAS NOTIFIED THAT THE TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) INSTRUMENTS WITH A 'WOODEN' HANDLE REQUIRED TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. THERE WAS NO PATIENT IMPACT AND NO DELAYS. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THERE WAS FOREIGN SUBSTANCE AT THE END OF THE HANDLE OF T-PLIF IMPACTOR-STRAIGHT. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT . THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583836 ↗
• MalfunctionMar 14, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DISCOVERED THAT ALL TPLIF INSTRUMENTS WITH A 'WOODEN' HANDLE NEEDS TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. TWO (2) SETS TO ADDRESS. NO PATIENT WAS IMPACTED AND NO DELAYS WERE OBTAINED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536971 ↗
• MalfunctionMar 13, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DISCOVERED THAT ALL TPLIF INSTRUMENTS WITH A 'WOODEN' HANDLE NEEDS TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. TWO (2) SETS TO ADDRESS. NO PATIENT WAS IMPACTED AND NO DELAYS WERE OBTAINED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530632 ↗
• MalfunctionFeb 24, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON FELT TIP WAS WARN CAUSING IMPLANT TO BE LOOSE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436802 ↗
• MalfunctionJan 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON INSERTED A TPLIF HOLDER, DURING THIS PROCESS, THE TPLIF HOLDER AT THE DISTAL END PRONG BENT. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ANY DELAYS OR CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249682 ↗
• MalfunctionJun 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DR. WAS DOING AN ANTERIOR AND POSTERIOR APPROACH ON THE SAME PATIENT. FOR THE POSTERIOR APPROACH, UPON IMPACTING THE TPLIF CAGE, THERE WAS 'DUST/POWDER' COMING OUT OF THE TPLIF IMPACTOR (WHERE THE METAL END MEETS THE HANDLE). THE SURGEON COMPLETED THE CASE WITH ANOTHER IMPACTOR. AND FOR THE ANTERIOR APPROACH WITH THE SYNFRAME, THE REGION WHERE THE GUIDE ROD HOLDS THE BLADE BROKE (TWO GUIDE RODS BROKE DURING BLADE INSERTION). IN BOTH CASES THE PATIENT WAS NOT IMPACTED AND THERE WAS NO DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678848 ↗
• MalfunctionMay 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT ON (B)(6) 2022, THE SURGEON WAS DOING A SPINAL CASE USING THE TLIF AND THE SYNMESH SYSTEMS. WHILE DOING SO, USING THE TLIF GRAFT PUSHER THE PROXIMAL END HAD A PLATE OF 'METAL' FOLLOWED BY THE HANDLE. IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING THE TLIF CAGE FURTHER, THERE WAS SOME SORT OF POWDER THAT CAME OUT BETWEEN THE METAL PLATE AND THE HANDLE. THE SAME INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14472060 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION AT STERILE PROCESSING, THE SCREW OF A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) IMPLANT HOLDER FELL OUT OF THE HOLDER. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9455815 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10MM TRIAL SPACER 12MM HEIGHT. THIS IS REPORT 3 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144939 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10 MM TRIAL SPACER 15 MM HEIGHT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144930 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMERED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10MM TRIAL SPACER 10MM HEIGHT. THIS IS REPORT 1 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144928 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10MM TRIAL SPACER 7MM HEIGHT. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144655 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER SEPTEMBER 5, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10 MM TRIAL SPACER 9MM HEIGHT. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144650 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10MM TRIAL SPACER 8MM HEIGHT. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144647 ↗

Other Synthes GmbH products

• TFN-ADVANCE195 models · 1,031 reports · 5 recalls
• LCP367 models · 1,102 reports · 1 recall
• VA-LCP256 models · 813 reports
• Matrix80 models · 597 reports
• T-PAL37 models · 544 reports
• MatrixNEURO25 models · 422 reports
• KINCISE16 models · 417 reports
• MULTILOC48 models · 402 reports