SynFrame 387.346Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034771120), received between Sep 6, 2018 and Jan 5, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THE CLAMP HAD A BROKEN/MISSING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957954 ↗
• MalfunctionAug 27, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE SURGEON WAS DOING A MAS DECOMPRESSION AND THE INSTRUMENT WAS LOOSE AND OLD. ADDITIONALLY DEVICE SYNFRAME INSULATED TABLE CLAMP WAS NO LONGER PROPERLY HOLDING THE ROD. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909409 ↗
• MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE ITEMS WERE FOUND NOT TO BE WORKING PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675627 ↗
• MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS FOUND THAT THESE ITEMS WERE NOT WORKING PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675465 ↗
• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE THE TABLE CLAMPS NO LONGER WORK AND SECURE TO THE TABLE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338652 ↗
• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE THE TABLE CLAMPS NO LONGER WORK AND SECURE TO THE TABLE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338594 ↗
• MalfunctionOct 30, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TUBES WERE DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565980 ↗
• MalfunctionOct 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW WAS UNABLE TO BE TURNED. THE ISSUE WAS AN UNREPAIRABLE LETTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20506812 ↗
• MalfunctionApr 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145139 ↗
• MalfunctionApr 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE SYNFRAME INSULATED TABLE CLAMP THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145124 ↗
• MalfunctionMar 3, 2022Compatibility Problem; Compatibility Problem

  SCREW DOES NOT ROTATE. ISSUE AN UNREPAIRABLE LETTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SYNFRAME HOLDING BASE INSULATED F/OR TAB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659496 ↗
• MalfunctionJan 5, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN POSTERIOR CERVICAL TUMOR REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, UPON OPENING THE SET THE SYNFRAME INSULATED TABLE CLAMP WAS COMPLETELY JAMMED/OVERTIGHTENED AND WAS UNUSABLE. AN ALTERNATIVE TABLE CLAMP WAS USED TO SOLVE THE PROBLEM. AFTER THAT IT WAS DISCOVERED THAT THE INSIGHT FLEX ARM CONTAINED WITHIN THE LOAN SET WOULDN¿T LOCK IN TO POSITION. IT REMAINED FLOPPY AND WOULDN¿T LOCK MAKING IT UNUSABLE. THE SURGEON WORKED AROUND THIS BY USING AN ALTERNATIVE RETRACTOR AND CONTINUED WITH THE OPERATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETE. THIS REPORT IS FOR ONE (1) SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169921 ↗
• MalfunctionDec 6, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSIGHT TUBES RETRACTOR FOR MIS TLIF; THE CLAMP WAS NOT HOLDING PROPERLY. NO ADVERSE EVENT WAS REPORTED. THIS REPORT IS FOR ONE (1) SYNFRAME HOLDING BASE INSULATED F/OR TAB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935703 ↗
• MalfunctionMay 24, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE EQUIPMENT, IT WAS FOUND THAT THREADED PORTION OF SCREW SHANK TO A NUT IS STUCK AND THREADS ARE DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE HOLDING CLIP COMPONENT WAS JAMMED. THIS REPORT IS FOR 1 SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872659 ↗
• MalfunctionMar 23, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON(B)(4) 2021 THAT DURING AN INVESTIGATION IT WAS NOTICED THAT THE BLACK SCREWS ARE TOO LIGHT AND CANNOT BE TURNED PROPERLY EVEN AFTER LUBRICATION. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SYNFRAME INSULATED TABLE CLAMP. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557936 ↗
• MalfunctionMar 23, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT DURING AN INVESTIGATION IT WAS NOTICED THAT THE BLACK SCREWS ARE TOO LIGHT AND CANNOT BE TURNED PROPERLY EVEN AFTER LUBRICATION. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SYNFRAME INSULATED TABLE CLAMP. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557912 ↗
• MalfunctionFeb 26, 2021Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AFTER OPENING THE SYNFRAME STANDARD ACCESS TRAY, THE SYNFRAME INSULATED TABLE CLAMP APPEARED TO BE BROKEN. THE BLACK TIGHTENING KNOB ON THE TABLE MOUNT CLAMP WAS JAMMED AND COULD NEITHER TURN TO OPEN OR CLOSE. AS A RESULT, IT COULD NOT BE SECURED TO THE BED AND USED FOR THE PROCEDURE. THIS ALL OCCURRED BEFORE THE PATIENT WAS IN THE OPERATING ROOM. A BACKUP TRAY WAS AVAILABLE AND OPENED FOR SURGERY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384729 ↗
• MalfunctionDec 25, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, WHILE THE NURSE WAS PUTTING THE HALF RING TOGETHER, IT WAS NOTICED THAT THE SCREW WAS BROKEN AND UNABLE TO TIGHTEN IT ONTO THE OTHER HALF RING TIGHTLY. WHILE TIGHTENING THE BLUE HOLDING BASE TO THE BED, THE BLUE SCREW MADE A LOUD CRACK NOISE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11073563 ↗
• 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 2 OF 9 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384627 ↗
• 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 1 OF 9 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384585 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE SYNFRAME INSULATED TABLE CLAMP WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME INSULATED TABLE CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10133581 ↗
• MalfunctionMar 20, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 2 SYNFRAME TABLE CLAMPS KEEP GETTING STUCK ON THE OPERATION TABLE RAILS AND ARE VERY DIFFICULT TO UNSCREW AT THE END OF SURGERY. OR STAFF HAD TO USE VISE GRIPS TO UNSCREW THE CLAMPS. IT¿S HAPPENED SEVERAL TIMES. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862365 ↗
• MalfunctionMar 20, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 2 SYNFRAME TABLE CLAMPS KEEP GETTING STUCK ON THE OPERATION TABLE RAILS AND ARE VERY DIFFICULT TO UNSCREW AT THE END OF SURGERY. OR STAFF HAD TO USE VISE GRIPS TO UNSCREW THE CLAMPS. IT¿S HAPPENED SEVERAL TIMES. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862354 ↗
• MalfunctionMar 20, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 2 SYNFRAME TABLE CLAMPS KEEP GETTING STUCK ON THE OPERATION TABLE RAILS AND ARE VERY DIFFICULT TO UNSCREW AT THE END OF SURGERY. OR STAFF HAD TO USE VISE GRIPS TO UNSCREW THE CLAMPS. IT¿S HAPPENED SEVERAL TIMES. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861822 ↗
• MalfunctionMar 20, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 2 SYNFRAME TABLE CLAMPS KEEP GETTING STUCK ON THE OPERATION TABLE RAILS AND ARE VERY DIFFICULT TO UNSCREW AT THE END OF SURGERY. OR STAFF HAD TO USE VISE GRIPS TO UNSCREW THE CLAMPS. IT¿S HAPPENED SEVERAL TIMES. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861821 ↗