T-PAL 08.812.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034759579), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 injury.

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.

• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2014, FOR TREATMENT OF SCOLIOSIS AND BACK PAIN. PATIENT WAS IMPLANTED WITH TWO (2) SYNTHES CONTOURED RODS, UNKNOWN QUANTITY AND TYPE OF EXPEDIUM SCREWS, THREE (3)UNKNOWN SPACERS (SIZE 9MM-10MM-11MM) AND ONE (1) SYNTHES T-PAL 12MM SPACER. PATIENT¿S ORIGINAL CONSTRUCT WAS FROM T9 TO S5 DISC LEVELS. IT IS UNKNOWN WHAT DISC LEVELS THE SPACERS WERE IMPLANTED. POST-OPERATIVELY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014, DUE TO A LOOSE SCREW ON THE LEFT SIDE T9 DISC LEVEL POSITION. THE PATIENT ALSO PRESENT WITH PAIN ISSUES. THE SURGEON REMOVED THE LOOSE THORACIC EXPEDIUM PEDICLE SCREW AT THE T9 DISC SPACE AND EXTENDED THE CONSTRUCT TO INCLUDE THE T8 DIS SPACE. POST-OPERATIVELY, ANOTHER REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, DUE TO HARDWARE FAILURE. THE PATIENT PRESENTING WITH A FRACTURE AT T9 DISC LEVEL WITH REPORTED PATIENT PAIN. THE SURGEON REMOVED THE HARDWARE FROM THE T9 DISC SPACE. HE REMOVED AND REPLACED LEFT PEDICLE SCREW AT T10 DISC SPACE WITH A KYPHOPLASTY AND VERTEBROPLASTY PROCEDURE AT THE T10 DIS SPACE. ADDITIONALLY, THE RODS WERE REPLACED WITH SHORTER LENGTHS THAT EXTENDED TO THE T9 -S5 DISC LEVELS.

  Patient problems: Pain

  MAUDE report 7378278 ↗

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