SynFrame 387.343Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034771090), received between May 25, 2017 and Jul 28, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (4 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 22632533 ↗
• 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 22632316 ↗
• MalfunctionJun 12, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE POST FROM TABLE MOUNT AFTER THE CASE. AFTER CLOSER EXAMINATION, END OF TABLE POST APPEARED TO BE VERY BENT, AND WAS UNABLE TO SLIDE SMOOTHLY THROUGH TABLE MOUNT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194427 ↗
• MalfunctionFeb 21, 2025Mechanical Problem; Use of Device Problem; Compatibility Problem; Mechanical Problem; Use of Device Problem; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437717 ↗
• 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 21158696 ↗
• 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 21158616 ↗
• MalfunctionAug 10, 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 9 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384761 ↗
• MalfunctionAug 10, 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 3 OF 9 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384692 ↗
• InjuryMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT DURING A PRIMARY SPINE SURGERY ON (B)(6) 2017, IT WAS NOT POSSIBLE TO INSERT THE FLEX-ARM INSIDE THE SYNFRAME GUIDING TUBE. ADDITIONALLY IT WAS NOT POSSIBLE TO LOCK THE FLEX-ARM. THE SURGEON HAD TO CHANGE HIS PROCEDURE AND THE PATIENT WAS NOT IMPLANTED WITH A CAGE. THE PATIENT MAY HAVE TO COME BACK FOR A NEW INTERVENTION. THE SURGERY WAS PROLONGED ABOUT FIFTEEN (15) MINUTES BUT THERE WAS NO PATIENT HARM. NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME AND CONDITION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6590382 ↗