SynFrame 387.353Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034771144), received between Aug 7, 2020 and Dec 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Compatibility 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, BOTH OF THE CLAMPS WILL NO LONGER TIGHTEN. THEY WERE UNABLE TO BE USED WITH THE RETRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832357 ↗
• MalfunctionDec 17, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, BOTH OF THE CLAMPS WILL NO LONGER TIGHTEN. THEY WERE UNABLE TO BE USED WITH THE RETRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832354 ↗
• MalfunctionFeb 8, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NOTICED THAT THE CLAMP WAS NOT TIGHTENING ADEQUATELY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS INSTRUMENT BUT SURGEON WANTED TO REPLACED AS IT IS NOT PERFORMING AS IT SHOULD. NO REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) SYNFRAME TUBE-TUBE CLAMP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479781 ↗
• MalfunctionAug 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ALL PARTS OF A SPINE KIT THAT NEED TO BE TIGHTENED OR LOCKED NEED TO BE LUBRICATED. THIS WAS NOTED DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE ON (B)(6) 2020 WHERE THERE WERE DEVICE INTERACTION ISSUES. ADDITIONALLY, 2 BLUE CLAMPS HAVE BEEN TAGGED BECAUSE THEY WERE NOT GRIPPING TO THE O-RING PROPERLY. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380428 ↗
• MalfunctionAug 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ALL PARTS OF A SPINE KIT THAT NEED TO BE TIGHTENED OR LOCKED NEED TO BE LUBRICATED. THIS WAS NOTED DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE ON (B)(6) 2020 WHERE THERE WERE DEVICE INTERACTION ISSUES. ADDITIONALLY, 2 BLUE CLAMPS HAVE BEEN TAGGED BECAUSE THEY WERE NOT GRIPPING TO THE O-RING PROPERLY. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380357 ↗