SynFrame 387.334Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034771038), received between Jul 9, 2019 and Apr 30, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SCRUB NURSE WAS ASSEMBLING THE RING FOR THE SYNFRAME WHEN SHE REALIZED THERE WAS LOT OF MOVEMENT IN THE ARTICULATING PORTION OF THE ATTACHMENT. UPON FURTHER INSPECTION, A TOOTH ON THE ATTACHMENT WAS BROKEN OFF AND WAS NO LONGER THERE. THE NURSE REPLACED THE INSTRUMENT SET WITH A NEW ONE. FRAGMENTS WERE NOT GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935440 ↗
• MalfunctionNov 25, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM HAD A SCREW SIDEWAYS/STUCK. THE PATIENT WAS NOT AFFECTED BY THIS OTHER THAN DELAYED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773696 ↗
• MalfunctionSep 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE IN 2024, IT WAS NOT POSSIBLE TO DEPRESS THE SNAP LOCK BUTTON TO CHANGE ANGLE AT JOINT ON A SYNFRAME-EXTENSION WITH JOINT. THIS REPORT IS FOR A SYNFRAME EXTENSION-ADJUSTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246987 ↗
• MalfunctionJul 16, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE KNOB WHICH TIGHTENS THE HINGE SHEARED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181271 ↗
• MalfunctionMay 11, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) SYNFRAME EXTENSION INSTRUMENTS WERE FOUND TO BE WORN OUT. UPON INSPECTION, IT WAS STATE THAT THE TEETH ON THE JOINTS LOOKED WORN OUT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807835 ↗
• MalfunctionMay 11, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) SYNFRAME EXTENSION INSTRUMENTS WERE FOUND TO BE WORN OUT. UPON INSPECTION, IT WAS STATE THAT THE TEETH ON THE JOINTS LOOKED WORN OUT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807725 ↗
• 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) CASE, THAT THE SYNFRAME INSTRUMENTS NEEDED TO BE LUBRICATED AND TWO (2) CLAMPS NEEDED TO BE REPLACED DUE TO THE CLAMPS NOT GRIPPING THE O-RING PROPERLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: O-RING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (PART 387.347, LOT UNKNOWN, QUANTITY 1), SYNFRAME ½RING F/HOLDINGRING NO. 387.336 (PART 387.337, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION F/387.336+387.337 (PART 387.338, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 1), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNOWN, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT, (B)(4), CAPTURES 10 OF 36 DEVICES, AND IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384849 ↗
• 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) CASE, THAT THE SYNFRAME INSTRUMENTS NEEDED TO BE LUBRICATED AND TWO (2) CLAMPS NEEDED TO BE REPLACED DUE TO THE CLAMPS NOT GRIPPING THE O-RING PROPERLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: O-RING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (PART 387.347, LOT UNKNOWN, QUANTITY 1), SYNFRAME ½RING F/HOLDINGRING NO. 387.336 (PART 387.337, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION F/387.336+387.337 (PART 387.338, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 1), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNOWN, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT, (B)(4), CAPTURES 10 OF 36 DEVICES, AND IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384687 ↗
• MalfunctionApr 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON FEBRUARY 17, 2020, DURING EVALUATION OF THE DEVICES TWO (2) SYNFRAME EXTENSIONS WERE FOUND UNABLE TO BE STRAIGHTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9912433 ↗
• MalfunctionApr 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON FEBRUARY 17, 2020, DURING EVALUATION OF THE DEVICES TWO (2) SYNFRAME EXTENSIONS WERE FOUND UNABLE TO BE STRAIGHTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9912370 ↗
• MalfunctionJul 9, 2019Break; Mechanical Jam; Break; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2019 , THE SYNFRAME EXTENSION WITH SNAP IN LOCKING WAS NOT FUNCTIONING PROPERLY DURING THE PROCEDURE. FOLLOWING THE CASE, THE SYNFRAME EXTENSION WAS BEING DISASSEMBLED AND THE STAFF NOTED THAT IT HAD JAMMED. THE SURGEON TRIED TO STRAIGHTEN UP THE SYNFRAME EXTENSION, HOWEVER, THE BUTTON WAS NOT USED TO RETRACT TO FREE THE SYNFRAME EXTENSION. THE STOP BROKE OFF WHEN FORCE WAS APPLIED AND THE POSITION OF THE SYNFRAME EXTENSION CANNOT BE FIXED. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771317 ↗