SynFrame 387.344Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034771106), received between Aug 7, 2020 and Jul 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THESE WERE LOT NUMBERS OF THE PRODUCT:1050769-1 X21051599 X21649874 X2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632792 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON WAS DOING A MAS DECOMPRESSION AND THE INSTRUMENT WAS FOUND LOOSE AND OLD, NEEDED REPLACING. THERE WAS NO DELAY TO SURGERY AND THE PATIENT WAS NOT AFFECTED. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632496 ↗
• MalfunctionJan 15, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE SURGEON USED THE SYNFRAME AND FOUND THAT ALL COMPONENTS ARE BECOMING OLD AND NEEDED TO BE REPLACED. THIS SYNFRAME IS OVER 20 YEARS OLD AND IS STARTING TO SHOW ITS AGE. THE CASING IS FALLING APART, PARTS PEELING OFF AND THE INSTRUMENT ARE BECOMING DIFFICULT TO ASSEMBLE. NO PATIENT WAS INVOLVED AS THIS OCCURED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158684 ↗
• MalfunctionJan 15, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE SURGEON USED THE SYNFRAME AND FOUND THAT ALL COMPONENTS ARE BECOMING OLD AND NEEDED TO BE REPLACED. THIS SYNFRAME IS OVER 20 YEARS OLD AND IS STARTING TO SHOW ITS AGE. THE CASING IS FALLING APART, PARTS PEELING OFF AND THE INSTRUMENT ARE BECOMING DIFFICULT TO ASSEMBLE. NO PATIENT WAS INVOLVED AS THIS OCCURED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158673 ↗
• 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 8 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381892 ↗
• 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 9 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381864 ↗