T-PAL 08.812.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034759531), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100089); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION ON (B)(6) 2018, THE BACK PORTION OF THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER BROKE OFF WHILE IMPACTING INTO THE DISC SPACE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) 10MM X 28MM T-PAL SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693819 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100089. One submission often covers many models, so check the product and lot details in each record.

• Z-0161-2012 · Sep 23, 2011 · Terminated
  Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is ind