T-PALRecalls & reported problems across all models
Synthes GmbH · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 544
- Deaths reported
- 0
- Injuries reported
- 96
- Recalls
- 0
We found 37 models of T-PAL by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 544 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2015 and Jun 30, 2025 — classified as 96 injuries, 448 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (129 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
Reports received per month, all models
Most reported T-PAL problems
Device problems
- Compatibility Problem129
- Device-Device Incompatibility125
- Break102
- Material Integrity Problem52
- Mechanical Jam34
- Adverse Event Without Identified Device or Use Problem27
- Device Operates Differently Than Expected26
- Mechanical Problem20
Patient problems
- No Clinical Signs, Symptoms or Conditions161
- No Consequences Or Impact To Patient151
- No Known Impact Or Consequence To Patient87
- No Code Available55
- No Patient Involvement44
- Insufficient Information17
- Joint Laxity16
- Nonunion/Delayed-union Bone Fracture10
T-PAL models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- T-PAL 03.812.003Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Intervertebral fusion device with bone graft, lumbar120 reports
- T-PAL 03.812.001Intervertebral fusion device with bone graft, lumbar76 reports
- T-PAL 03.812.521Intervertebral fusion device with bone graft, lumbar58 reports
- T-PAL 03.812.520Intervertebral fusion device with bone graft, lumbar55 reports
- T-PAL 03.812.310TEMPLATE10 reports
- T-PAL 03.812.308TEMPLATE8 reports
- T-PAL 03.812.307TEMPLATE7 reports
- T-PAL 03.812.311TEMPLATE5 reports
- T-PAL 04.812.210SIntervertebral fusion device with bone graft, lumbar5 reports
- T-PAL 03.812.511TEMPLATE4 reports
- T-PAL 04.812.211SIntervertebral fusion device with bone graft, lumbar4 reports
- T-PAL 04.812.010SIntervertebral fusion device with bone graft, lumbar4 reports
- T-PAL 08.812.007Intervertebral fusion device with bone graft, lumbar3 reports
- T-PAL 03.812.309TEMPLATE2 reports
- T-PAL 03.812.507TEMPLATE2 reports
- T-PAL 03.812.515TEMPLATE2 reports
- T-PAL 08.812.009Intervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 08.812.010Intervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 08.812.011Intervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 04.812.008SIntervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 04.812.009SIntervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 04.812.007SIntervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 04.812.011SIntervertebral fusion device with bone graft, lumbar2 reports
- T-PAL 03.812.510TEMPLATE1 report
- T-PAL 03.812.512TEMPLATE1 report
- T-PAL 08.812.008Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL 08.812.012Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL 08.812.209Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL 08.812.211Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL 08.812.213Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.217SIntervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.015SIntervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.212SIntervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.012SIntervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.013SIntervertebral fusion device with bone graft, lumbar1 report
- T-PAL 04.812.213SIntervertebral fusion device with bone graft, lumbar1 report
Recent T-PAL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PARTS FOR THE INSERTER IS SEIZED AND CAN NOT BE TAKEN APART. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367141 ↗MalfunctionJun 30, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PARTS FOR THE INSERTER IS SEIZED AND CAN NOT BE TAKEN APART. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366538 ↗MalfunctionJun 23, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING A PROCEDURE A TPAL 10MM SMALL TRAIL DAMAGED IN THEATRE. THE TRIAL WAS INSERTED INTO THE SHAFT BUT WOULD NOT ENGAGE THE APPLICATOR KNOB, IT LOOKED LIKE THE LOCKING MECHANISM ON THE TRIAL HAS BROKEN OFF INSIDE THE APPLICATOR KNOB, MEANING THE APPLICATOR KNOB ALSO CAN NOT BE USED. THERE WAS NO PATIENT HARM, NO DELAY TO SURGERY, AND NO ADVERSE EVENT AS THERE WAS A SECOND KIT AVAILABLE IN THEATRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309854 ↗MalfunctionMay 13, 2025Compatibility Problem; Compatibility Problem
IT WAS REPORTED THE KNOB OF THE INSTRUMENT GOT CAUGHT IN THE TRIAL CAGE AND CANNOT BE REMOVED. THERE WERE NO CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION/REVISION PROCEDURE REQUIRED.
Patient problems: Insufficient Information
MAUDE report 22011270 ↗MalfunctionApr 21, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THE KNOB OF THE INSTRUMENT GOT CAUGHT IN THE TRIAL CAGE AND CANNOT BE REMOVED. THERE WERE NO CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION/REVISION PROCEDURE REQUIRED.
Patient problems: Insufficient Information
MAUDE report 21871852 ↗MalfunctionOct 14, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THIS WAS A TLIF (L5/S1) FOR LUMBAR CANAL STENOSIS ON (B)(6) 2024. DURING SURGERY, THE SURGEON FILLED GRAFTED BONE AFTER DISC DISSECTION AND INSERTED THE CAGE AS PER TECHNIQUE USING AN INSERTER. WHEN THE TIP OF THE INSERTER WAS BEYOND THE POSTERIOR WALL OF THE VERTEBRAL BODY, THE SALES REP INFORMED THE SURGEON TO TURN THE KNOB TO THE LEFT TO THE POINT WHERE IT STOPPED BEFORE PERFORMING THE ROTARY OPERATION. IT WAS CONFIRMED THAT THE CAGE WAS PLACED IN THE OPTIMAL POSITION WHEN THE IMAGE WAS CHECKED AT THE SIDE AND FRONT OF THE IMAGE. THE SURGEON ATTEMPTED TO REMOVE THE INSERTER, HOWEVER, WAS UNABLE TO REMOVE IT FROM THE CAGE. THEREFORE, LEAVING ONLY THE SHAFT, THE SURGEON REMOVED THE INSERTER BODY FROM THE CAGE. THE SHAFT COULD NOT BE REMOVED, AFTER CHANGING THE ANGLE AT WHICH THE SHAFT WAS HELD SIGNIFICANTLY, IT COULD FINALLY BE REMOVED. WHEN CHECKED OUTSIDE THE SURGICAL FIELD, THE TIP OF THE SHAFT WAS FOUND TO BE SEVERELY BENT AND DEFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20442010 ↗MalfunctionOct 9, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING INSPECTION OF A SET BY ORTHOKIT EMPLOYEES THERE WAS BREAKDOWN NOTED. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409527 ↗MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716087 ↗MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) FOR SPONDYLOLISTHESIS ON (B)(6) 2024. IN THE SURGERY, WHEN THE SURGEON TURNED THE INSERTER DOWN TO ATTACH IT TO THE CAGE, IT FELL TO THE FLOOR WHERE THE SHAFT SLID STRAIGHT OUT. A NEW PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE TIP OF THE HANDLE SIDE OF THE SHAFT WAS MISSING, WHICH REMAINED INSIDE THE HANDLE AND COULD NOT BE GRASPED AT ALL. IT IS UNKNOWN AT WHAT POINT THE BREAKAGE OCCURRED. PATIENT WAS STABLE. THIS REPORT IS FOR A T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713578 ↗MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713459 ↗MalfunctionJun 5, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024 , WHEN INSERTING THE SAMPLE CAGE, THE UPPER PART OF THE SAMPLE CAGE BROKE. THE REMAINING TIP WAS LEFT IN THE INSTRUMENT, BUT IT WAS REMOVED AFTER SURGERY. THE CAGE CAN NO LONGER BE USED. SURGERY WAS EXTENDED BY APPROXIMATELY 15 MINUTES DUE TO THE EVENT, AND WAS MANAGED WITH A SIMILAR PRODUCT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR A T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19470215 ↗MalfunctionJun 4, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2024, PRE-OPERATIVELY IT WAS NOTICED THAT THE BALL CLIP (DISTAL END) ON THE TWO INSTRUMENTS ARE MISSING, AND ONE OF WHICH WAS JAMMED IN THE HANDLE. THE DEVICE HAS NOT BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 7MM HEIGHT THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459906 ↗MalfunctionJun 4, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem
IT WAS REPORTED THAT ON APRIL 30, 2024, PRE-OPERATIVELY IT WAS NOTICED THAT THE BALL CLIP (DISTAL END) ON THE TWO INSTRUMENTS ARE MISSING, AND ONE OF WHICH WAS JAMMED IN THE HANDLE. THE DEVICE HAS NOT BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459900 ↗MalfunctionJun 4, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2024, PRE-OPERATIVELY IT WAS NOTICED THAT THE BALL CLIP (DISTAL END) ON THE TWO INSTRUMENTS ARE MISSING, AND ONE OF WHICH WAS JAMMED IN THE HANDLE. THE DEVICE HAS NOT BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459898 ↗MalfunctionApr 15, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT THIS WAS A TLIF FOR A DEGENERATION ON (B)(6) 2024. WHEN THE APPLICATOR KNOB AND ADVANCED APPL OUTER SHAFT WAS ASSEMBLED, BOTH PRODUCTS STUCK AND COULD NOT BE DETACHED. SUBSTITUTES WERE USED IN THE SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADVANCED APPL OUTER SHAFT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19108171 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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