T-PLIF 389.269Recalls & reported problems
Synthes GmbH · T-PLIF 10MM TRIAL SPACER 11MM HEIGHT · Class 1
All models of T-PLIF (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034775241), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 malfunction.
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 JULY 17, 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 11MM HEIGHT. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9144644 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page