NA 03.609.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034713014), received between Jun 15, 2020 and Nov 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON OCTOBER 16, 2023, THAT THE TOP OF BOTH OF THESE PROACCESS BLADES ARE BENT AND DO NOT CLIP PROPERLY ON TO THE GUIDE RODS OF THE SYNFRAME RING. OTHER SIZE BLADES WERE USED TO COMPLETE THE SURGERY. NO CHARGE REPLACEMENTS WILL BE NEEDED. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) RADIOLUCENT RETRACTOR BLADE 25MM X 140MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085948 ↗
• MalfunctionSep 29, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SPINAL FUSION SURGERY, THE SURGEON WAS HAVING DIFFICULTY ATTACHING THE BLADE TO THE ¿STICK¿ TO THE SYNFRAME RING. IT SEEMED TO BE DAMAGED AT THE PROXIMAL END. ANOTHER BLADE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT AND NO DELAY IN SURGERY. THIS REPORT INVOLVES ONE RADIOLUCENT RETRACTOR BLADE 25MM X 140MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504757 ↗
• MalfunctionJun 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS DOING A LATERAL ORACLE INTERBODY FUSION WITH SYNTHES SYNFRAME RETRACTOR, DURING THE EXPOSURE OF THE PATIENT, AND THE PLACEMENT OF THE SYNFRAME RETRACTOR ONE OF THE PROACCESS RADIOLUCENT BLADES BROKE. FRAGMENTS WERE NOT GENERATED FROM A BROKEN DEVICE. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT AND ANOTHER BLADE WAS AVAILABLE FOR USE. CONCOMITANT DEVICES REPORTED: REDUCTION/RETRACTION/DISTRACTION INSTRUMENTS: SPINE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 RADIOLUCENT RETRACTOR BLADE 25MM X 140MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10154450 ↗