SYNFIX Evolution 03.835.012SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034814216), received between Jul 11, 2019 and Jul 23, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (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 16, 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 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANTERIOR SPINAL FUSION, ONE (1) OUT OF THREE (3) SYNFIX EVOLUTION PROTECTION SLEEVE WAS LOST. TWO (2) SLEEVES WERE LOCATED ON THE BACK OF THE TABLE, THE THIRD WAS NOT LOCATED. THE SURGEONS VISUALLY INSPECTED THE WOUND AND COULD NOT LOCATE THE ITEM. A SEARCH WAS ALSO CONDUCTED IN THE OPERATING ROOM WITH NO FINDING OF THE ITEM.  A CT SCAN WAS PERFORMED POST-OPERATIVELY, THE SLEEVE WAS LOCATED AT THE ANTERIOR PROMINENCE OF S1. THERE WAS NO FURTHER SURGICAL ACTION IS BEING TAKEN AT THIS POINT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.  THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8817593 ↗
• InjuryJul 11, 2019Device Slipped; Component Missing

  PRODUCT SLIPPED OFF DEVICE DURING SURGERY, DIFFICULT TO FIND WHEN COVERED IN BLOOD AND TISSUE. ALSO PRODUCT IS NOT RADIOPAQUE SO INTRA OP XRAY DOES NOT DETECT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785382 ↗