SynFrame 387.338Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034771076), received between Oct 17, 2018 and Aug 10, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 1), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 2), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNWON, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME LENGTHENER. THIS IS REPORT 5 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 10384660 ↗
• 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 1), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 2), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNOWN, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME LENGTHENER. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT, (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384629 ↗
• MalfunctionApr 10, 2020Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNFRAME EXTENSIONS ARE FAULTY; THE SCREWS ARE IN THE INCORRECT ORIENTATION AND THUS THE RING COULDN¿T BE ASSEMBLED. THE SURGICAL STAFF WERE ABLE TO USE BREAKABLE SYNFRAME HINGES AS EXTENDERS INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SYNFRAME HOLDING RING (PART: 387.336, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME 1/2 RING (PART: 387.337, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME EXTENSION (PART: 387.338, LOT: 4L53724, QUANTITY: 1) THIS REPORT IS FOR A SYNFRAME LENGTHENER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9950050 ↗
• MalfunctionApr 10, 2020Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNFRAME EXTENSIONS ARE FAULTY; THE SCREWS ARE IN THE INCORRECT ORIENTATION AND THUS THE RING COULDN¿T BE ASSEMBLED. THE SURGICAL STAFF WERE ABLE TO USE BREAKABLE SYNFRAME HINGES AS EXTENDERS INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SYNFRAME HOLDING RING (PART: 387.336, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME 1/2 RING (PART: 387.337, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME EXTENSION (PART: 387.338, LOT: 4L53724, QUANTITY: 1) THIS REPORT IS FOR A SYNFRAME LENGTHENER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9950035 ↗
• MalfunctionMar 16, 2020Compatibility Problem; Compatibility Problem

  UPDATED ED: CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME HALF RING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 9836800 ↗
• MalfunctionMar 16, 2020Compatibility Problem; Compatibility Problem

  UPDATED ED: CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME HALF RING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 9836798 ↗
• MalfunctionFeb 7, 2020Device Difficult to Setup or Prepare; Use of Device Problem; Device Difficult to Setup or Prepare; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NEWLY BOUGHT SYNFRAME EXTENSION CANNOT BE CONNECTED TO THE SYNFRAME RING WHICH IS ALREADY AVAILABLE AT THE HOSPITAL. ISSUE WAS NOTED DURING ASSEMBLY. ONE OF THE DARK BLUE HOLDING SOCKETS (387.346) COULD NOT BE ADJUSTED. AS A RESULT OF THIS THE TIGHTENING OF THE GUIDE ARM (387.343) WAS NOT POSSIBLE. NO SURGERY WAS AFFECTED AND NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME HALF RING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9684028 ↗
• MalfunctionFeb 7, 2020Device Difficult to Setup or Prepare; Use of Device Problem; Device Difficult to Setup or Prepare; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NEWLY BOUGHT SYNFRAME EXTENSION CANNOT BE CONNECTED TO THE SYNFRAME RING WHICH IS ALREADY AVAILABLE AT THE HOSPITAL. ISSUE WAS NOTED DURING ASSEMBLY. ONE OF THE DARK BLUE HOLDING SOCKETS (387.346) COULD NOT BE ADJUSTED. AS A RESULT OF THIS THE TIGHTENING OF THE GUIDE ARM (387.343) WAS NOT POSSIBLE. NO SURGERY WAS AFFECTED AND NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME HALF RING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9684027 ↗
• MalfunctionOct 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, DURING AN EVALUATION IN THE LOANERS DEPARTMENT THE SYNFRAME HALF RING AND SYNFRAME LENGTHENER WERE DIFFICULT TO UNSCREW. PROCEDURE AND PATIENT INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) SYNFRAME LENGTHENER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974877 ↗