T-PAL 04.812.010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034817156), received between Dec 24, 2019 and Jan 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: FAILURE TO REACH THERAPEUTIC GOALS, HARDWARE REMOVAL, IMPLANT FAILURE, SPINAL IMBALANCE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE T-PAL TI, MATRIX PERFORATED, MATRIX /OTHER AND MATRIX PRODUCTS (T-PAL TI SPACER 10MM X 28MM 10MM HT - ST (B)(4)).

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 18469575 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE T-PAL TI PRODUCTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18468406 ↗
• InjuryJan 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT MALPOSITION, INSTABILITY, NON-UNION, POSTOPERATIVE INFECTION DEEP, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT IS FOR A T-PAL TI SPACER 10MM X 28MM 10MM HEIGHT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 18467636 ↗
• InjuryDec 24, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE TPAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR) TITANIUM SPACER DUE TO THE REPORTED T-PAL SPACER THAT HAD MIGRATED OUT OF THE L4-L5 DISC SPACE. INITIALLY, THE PATIENT UNDERWENT AN L3-L5 TLIF POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGICAL OUTCOME IS UNKNOWN BUT WITH A PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9517076 ↗