SynFrame 387.358Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705034771168), received between Jan 13, 2017 and Sep 17, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Compatibility Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809744 ↗
• MalfunctionApr 23, 2026Compatibility Problem; Material Integrity Problem

  THE SCREW ON THE ROD GUIDE FROM THE SYNFRAME (RIGHT SIDE) IS STRIPPED. THE NURSE WAS UNABLE TO ATTACH A BLADE. THE INSTRUMENT NEEDS TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966477 ↗
• MalfunctionSep 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED SYNFRAME ARM WAS BROKEN IN THE THREADED AREA THAT THE THUMB SCREW/TIGHTENING BOLT GOES IN. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. THE PROCEDURE CONTINUED AND WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951113 ↗
• MalfunctionJun 20, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON MAY 30, 2025, ITEM THE SYNFRAME RETRACTOR HOLDER TIGHTENING NUT WAS SEIZED. THE SYNFRAME HALF RING TIGHTENING NUT WAS STRIPPED AND NO LONGER HOLDING THE TWO HALF RINGS TOGETHER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302197 ↗
• MalfunctionApr 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, IT WAS NOTED FOUR ITEMS FROM THE SYNFRAME SET WERE DAMAGED/LONGER WORKING. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOTED THE DEVICES WERE WORN, STRIPPED AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805981 ↗
• MalfunctionApr 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 , IT WAS NOTED FOUR ITEMS FROM THE SYNFRAME SET WERE DAMAGED/LONGER WORKING. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOTED THE DEVICES WERE WORN, STRIPPED AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805927 ↗
• MalfunctionApr 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, IT WAS NOTED FOUR ITEMS FROM THE SYNFRAME SET WERE DAMAGED/LONGER WORKING. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOTED THE DEVICES WERE WORN, STRIPPED AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805899 ↗
• 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 21439591 ↗
• 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 21437688 ↗
• MalfunctionJan 7, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SYNFRAME GUIDE ROD WAS RETURNED FROM THE FIELD WITH A STRIPPED/SEIZED SCREW. THIS WAS NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN THE WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093006 ↗
• MalfunctionSep 18, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE IN 2024, IT WAS NOT POSSIBLE TO TIGHTEN THE JOINT FOR THE CLAMP AT THE END OF THE SYNFRAME GUIDE ROD. THIS REPORT IS FOR A SYNFRAME GUIDE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247029 ↗
• MalfunctionJun 10, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT SET SCREW DOESN'T CONNECT THE PARTS. THE ISSUE WAS OBSERVED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE CONFIRMED PART IS NOT REPAIRABLE. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498512 ↗
• MalfunctionDec 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE INSPECTION AND CLEANING OF SYNFRAME GUIDE ROD INSTRUMENTS (3) THREE OF THE SYNFRAME ARTICULATING ARMS, WERE FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923975 ↗
• MalfunctionDec 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE INSPECTION AND CLEANING OF SYNFRAME GUIDE ROD INSTRUMENTS (3) THREE OF THE SYNFRAME ARTICULATING ARMS, WERE FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923930 ↗
• MalfunctionDec 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE INSPECTION AND CLEANING OF SYNFRAME GUIDE ROD INSTRUMENTS (3) THREE OF THE SYNFRAME ARTICULATING ARMS, WERE FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923913 ↗
• MalfunctionMar 29, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE SETTING UP FOR A SPINAL PROCEDURE, THREE (3) SYNFRAME GUIDE RODS WERE UNABLE TO HOLD BLADES FOR ADEQUATE RETRACTION. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585796 ↗
• MalfunctionMar 29, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 WHILE SETTING UP FOR A SPINAL PROCEDURE, THREE (3) SYNFRAME GUIDE RODS WERE UNABLE TO HOLD BLADES FOR ADEQUATE RETRACTION. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585770 ↗
• MalfunctionMar 29, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE SETTING UP FOR A SPINAL PROCEDURE, THREE (3) SYNFRAME GUIDE RODS WERE UNABLE TO HOLD BLADES FOR ADEQUATE RETRACTION. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585710 ↗
• MalfunctionMar 8, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE ATTACHMENT TO RETRACT ON THE GUIDE ROD WAS BROKEN AND WOULD NOT LOCK, WHICH CAUSED THE BLADE TO MOVE. ANOTHER BLADE WAS USED AND NEEDED TO BE HELD IN POSITION. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436062 ↗
• MalfunctionMar 8, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE ATTACHMENT TO RETRACT ON THE GUIDE ROD WAS BROKEN AND WOULD NOT LOCK, WHICH CAUSED THE BLADE TO MOVE. ANOTHER BLADE WAS USED AND NEEDED TO BE HELD IN POSITION. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435999 ↗
• MalfunctionFeb 23, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON JAN 29, 2021 THAT THE PATIENT UNDERWENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT THE REACTOR BLADES WERE NOT FITTING INTO THE GUIDE RODS PROPERLY. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RETRACTOR BLADES (PART: UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368949 ↗
• MalfunctionFeb 22, 2021Compatibility Problem; Compatibility Problem

  THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11360650 ↗
• MalfunctionNov 30, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE SCREW ON THIS INSTRUMENT IS NOT TIGHTENING ENOUGH TO KEEP THE INSTRUMENT FROM MOVING. THIS REPORT IS FOR ONE SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10921018 ↗
• MalfunctionAug 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE, THREE (3) SYNFRAME GUIDE RODS NEEDED LUBRICATION. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387279 ↗
• MalfunctionAug 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE, THREE (3) SYNFRAME GUIDE RODS NEEDED LUBRICATION. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SYNFRAME GUIDE ROD. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387256 ↗