T-PAL 03.812.308Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034727837), received between Feb 7, 2017 and Nov 17, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, AFTER IMPLANTATION OF THE TRIAL IMPLANT THE FRONT PART OF THE ADVANCED APPLICATOR OUTER SHAFT BROKE OFF. NO FRAGMENTS WERE GENERATED. THE TRIAL IMPLANT WAS REMOVED. THE OUTER SHAFT AND INNER PART OF THE TRIAL IMPLANT CAN NO LONGER BE REMOVED. ADDITIONALLY, TWO (2) ADVANCED APPLICATOR INNER SHAFTS BROKE OFF AT THE REAR END IN THE TAPER BALL CONNECTION AREA. ANOTHER SET OF INSTRUMENTS WAS AVAILABLE TO USE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) T-PAL SMALL TRIAL IMPLANT SIZ 8 NON DETA. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831679 ↗
• MalfunctionAug 4, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, AFTER THE DISC PREP, SURGEON PROCEEDED ON TO TESTING OUT THE TRIALS AND NOTICED THAT THE TRIAL CAGE STARTED TURNING AS HE WAS HAMMERING IT IN EVEN BEFORE HIM TURNING THE KNOB ON THE INSTRUMENT. IT WAS RESOLVED BY USING A DIFFERENT TRIAL AND APPLICATOR INSTRUMENT. THE CASE WAS FINISHED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276330 ↗
• MalfunctionOct 13, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-PAL TRIAL SPACER HAD A BROKEN TIP AND WAS NOT ENGAGING IN THE INSERTER. THE ISSUE WAS DISCOVERED DURING A TRAINING EXERCISE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - INSERTION INSTRUMENTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10671813 ↗
• MalfunctionMar 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE THE PART OF THE LUMBAR T-PAL LONG SHAFT OF THE TRIAL IMPLANT WAS FOUND LOOSE AND GOT STUCK IN THE UNKNOWN IMPLANT HOLDER. AFTER THE SURGERY WAS DONE THE INSTRUMENT WAS INSPECTED TO FIND OUT WHY THERE WAS TROUBLE WITH GETTING THE TRIAL IMPLANT OUT OF THE UNKNOWN INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER INSTRUMENT AND SETTING THE IMPLANT WITH ANOTHER ONE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. WHEN THE DEVICES WERE BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THE WELD ON THE T-PAL TRIAL SPACER IS BROKEN AND THEREFORE THE TWO PARTS CAN BE DISMANTLED INTO TWO PIECES. THIS REPORT IS FOR A T-PAL TRIAL SPACER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408699 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SPINE PROCEDURE FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THE SURGEON USED A TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR CAGE SYSTEM (TPAL) AND DURING THE OPERATION, THE T-PAL SMALL TRIAL IMPLANT WAS BROKEN DURING THE BACK-OUT PROCEDURE AFTER DOING THE TRIAL TESTING. THE ROUND REAR OF THE TPAL WAS BROKEN WHEN EXERTING THE PULLING BACKWARD WHILE USING AN UNKNOWN SLOT HAMMER DURING THE OPERATION. AN UNKNOWN WHOLE APPLICATOR DISASSEMBLED, THUS, THE SURGEON HAD TO USE A BARE HAND TO TAKE OUT THE TRIAL WITHOUT AN APPLICATOR. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A 15-MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: T-PAL APPLICATOR OUT SHAFT (PART#03.812.001, LOT# UNKNOWN, QUANTITY# 1); APPLICATOR KNOB (PART#03.812.004, LOT# UNKNOWN, QUANTITY#1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8276893 ↗
• InjuryJul 18, 2018Break; Break

  CANADA REPORTS THAT DURING A LUMBAR FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION (TILF) ON (B)(6) 2018, THE END PORTION OF THE 8MM TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (TPAL) TRIAL SPACER SHEARED OFF WHEN THE SURGEON TRIED TO TIGHTEN THE HANDLE. THE FRAGMENTS WERE RETRIEVED EASILY. THE SURGEON COMPLETED THE PROCEDURE USING A DIFFERENT TRIAL SIZE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY. PATIENT OUTCOME IS FINE. CONCOMITANT DEVICE: TRAUMA HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7700331 ↗
• MalfunctionJan 15, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED, THAT ON (B)(6) 2017, THE SURGERY FOR DEGENERATIVE SCOLIOSIS WAS PERFORMED BY USING TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) CAGE SYSTEM. THE FIXED AREA WAS L2 ¿ SAI. AFTER THE SURGEON DETERMINED THE SIZE OF THE T-PAL TRIAL IMPLANT BY FITTING, THE SURGEON THE TRIAL SPACER MOMENTARILY BY THE SLIDE HAMMER. WHEN THE NURSE WAS DETACHING THE T-PAL TRIAL SPACER FROM THE HANDLE OF THE SLIDE HAMMER, IT WAS FOUND THAT THE T-PAL TRIAL SPACER WAS DETACHED FROM THE HANDLE BEFORE RETURNING THE DETERMINED POSITION. WHEN LOOKED AT VERY CAREFULLY, IT WAS NOTICED THAT THE TIP OF THE ROUND PROTRUSION PART WAS BROKEN. THE SIDE BUTTON ON THE KNOB OF THE HOLDER COULD NOT BE PRESSED DOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: T-PAL TRIAL IMPLANT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SLIDE HAMMER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7190591 ↗
• MalfunctionFeb 7, 2017Break; Break

  THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6308997 ↗