NA 489.171Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034784359), received between Jul 21, 2022 and Jul 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED AN L2 LATERAL CORPECTOMY WITH SUPPLEMENTAL PLATE FIXATION FROM L1-L3 WITH DEPUY SYNTHES TSLP LATERAL PLATE ON (B)(6) 2021. THE SURGEON GOT X-RAYS IN (B)(6) 2022 SHOWING THE EXPANDABLE CAGE HAD SUBSIDED INTO THE L1 VERTEBRAL BODY WITH ONE OF THE SCREWS FROM THE TLSP PLATE IN L1 BODY BROKEN AT THE NECK OF THE SCREW CLOSE TO THE SCREW/PLATE INTERFACE. THE PATIENT WAS STABLE WITH NO CLINICAL ISSUES. THE PATIENT HAD EXPERIENCED A POST-OP DEVICE MALFUNCTION THIS REPORT IS FOR ONE (1) 5.5MM TI CANC LOCK SCRW 51MM THRD LGTH. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080325 ↗
• InjuryJul 21, 2022Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED AN L2 LATERAL CORPECTOMY WITH SUPPLEMENTAL PLATE FIXATION FROM L1-L3 WITH DEPUY SYNTHES TSLP LATERAL PLATE ON (B)(6) 2021. THE SURGEON GOT X-RAYS IN ( B)(6) 2022 SHOWING THE EXPANDABLE CAGE HAD SUBSIDED INTO THE L1 VERTEBRAL BODY WITH ONE OF THE SCREWS FROM THE TLSP PLATE IN L1 BODY BROKEN AT THE NECK OF THE SCREW CLOSE TO THE SCREW/PLATE INTERFACE. THE PATIENT WAS STABLE WITH NO CLINICAL ISSUES. THE PATIENT HAD EXPERIENCED A POST-OP DEVICE MALFUNCTION. THIS REPORT IS FOR ONE (1) 5.5MM TI CANC LOCK SCRW 51MM THRD LGTH. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080315 ↗