OPALRecalls & reported problems across all models

We found 10 models of OPAL by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2017 and Jun 27, 2025 — classified as 6 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OPAL problems

OPAL models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OPAL 03.803.002

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  19 reports
• OPAL 03.803.001

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  9 reports
• OPAL 08.803.053

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• OPAL 08.803.107

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• OPAL 03.803.008

  TEMPLATE
  1 report
• OPAL 08.803.051

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• OPAL 08.803.052

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• OPAL 08.803.108

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• OPAL 08.803.131

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• OPAL 08.803.210

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report

Recent OPAL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE PIECES BROKEN ON THE END OF THE HANDLE. THERE WAS NO PATIENT CONSEQUENCE. ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344365 ↗
• MalfunctionSep 9, 2024Contamination /Decontamination Problem; Compatibility Problem; Contamination /Decontamination Problem; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED AND STATING THAT: A. WAS THERE ANY SPECIFIC ALLEGATION AGAINST THE UNK - SCREWS: SPINE-US? IF YES, PLEASE PROVIDE DETAILS. NO. B. WAS OTHER MEDICAL INTERVENTION REQUIRED? IF YES, PLEASE SPECIFY DETAILS. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169562 ↗
• MalfunctionDec 7, 2023Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  DEVICE REPORT FROM ISRAEL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN A& P LUMBAR FUSION SURGERY ON (B)(6) 2023, THE CAGE HOLDER WAS MALFUNCTIONING WHEN TRYING TO INSERT THE CAGE. IT DID NOT HOLD THE CAGE TIGHTLY; THE HOLDER WAS LOOSE AND NOT STRONG ENOUGH TO ROTATE THE CAGE IN THE PATIENT'S BODY. THE SURGEON INSERTED THE CAGE STRAIGHT. THE SURGEON WAS PLEASED WITH THE RESULT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287506 ↗
• MalfunctionDec 5, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2023, THE IMPLANT WAS PLACED IN THE HOLDER AND INSERTED INTO THE INTERVERTEBRAL SPACE WITHOUT ANY PROBLEMS, BUT WHEN THE HOLDER WAS REMOVED AFTER THE IMPLANT WAS PLACED IN THE PROPER POSITION, THE KNOB OF THE HOLDER IN QUESTION COULD NOT BE TURNED. ONCE THE HOLDER COULD NO LONGER BE ROTATED EITHER CLOCKWISE OR COUNTERCLOCKWISE, AND ONCE THE HOLDER WAS PULLED OUT WITH THE ENTIRE IMPLANT, THE INSERTER¿S GRASPING MECHANISM WAS REMOVED AND ONLY THE IMPLANT WAS PLACED IN THE INTERVERTEBRAL SPACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO IMPACT TO THE PATIENT. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266723 ↗
• MalfunctionOct 24, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PLIF (L5/S1) WAS PERFORMED. THE SURGEON ATTEMPTED TO REMOVE THE CAGE INSERTED INTO THE RIGHT SIDE BECAUSE IT HAD BEEN INSERTED TOO FAR ANTERIOR. THE CAGE WAS DAMAGED DURING REMOVAL BECAUSE THERE WAS NO DEDICATED DEVICE TO REMOVE IT, THE SURGEON HAD DIFFICULTY REMOVING THE CAGE. ONLY 2 CAGES OF THE SAME SIZE HAD BEEN PREPARED, THE CAGE WITH THE SAME SIZE WAS UNABLE TO BE INSERTED AFTER THE CAGE IN QUESTION WAS DAMAGED. SUBSEQUENTLY, THE SURGEON INSERTED A CAGE SIZED LARGER (9 MM HEIGHT), AND IT WAS SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN OPAL SPACER 10MM X 28MM 7MM HEIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995992 ↗
• MalfunctionOct 24, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PLIF (L5/S1) WAS PERFORMED. THE SURGEON ATTEMPTED TO REMOVE THE CAGE INSERTED INTO THE RIGHT SIDE BECAUSE IT HAD BEEN INSERTED TOO FAR ANTERIOR. THE CAGE WAS DAMAGED DURING REMOVAL BECAUSE THERE WAS NO DEDICATED DEVICE TO REMOVE IT, THE SURGEON HAD DIFFICULTY REMOVING THE CAGE. ONLY 2 CAGES OF THE SAME SIZE HAD BEEN PREPARED, THE CAGE WITH THE SAME SIZE WAS UNABLE TO BE INSERTED AFTER THE CAGE IN QUESTION WAS DAMAGED. SUBSEQUENTLY, THE SURGEON INSERTED A CAGE SIZED LARGER (9 MM HEIGHT), AND IT WAS SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN OPAL SPACER 10MM X 28MM 7MM HEIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995989 ↗
• MalfunctionMay 20, 2021Compatibility Problem; Compatibility Problem

  THERE WAS A SURGICAL DELAY OF A FEW MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860346 ↗
• MalfunctionJan 7, 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 DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE IS 2020, THE KNOB THAT ATTACHES TO THE BACK OF THE INSERTER HANDLE IS CROSS THREADED AND WILL NOT RELEASE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132009 ↗
• MalfunctionSep 29, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A LUMBAR SPINAL FUSION PROCEDURE WITH THE EXPEDIUM VERSE AND OPAL SYSTEMS, A SMALL SCREW, FROM THE BACK OF THE INSERTER, BROKE OFF. THE SCREW BROKE WHEN IMPACTING THE OPAL SPACER INTO POSITION. THE SCREW WAS RECOVERED, AND THE INSERTER WAS REMOVED FROM THE FIELD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) OPAL IMPLANT HOLDER STRAIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599959 ↗
• MalfunctionMar 25, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. IT WAS PREOPERATIVELY FOUND THAT ONLY ONE GRIPPER WAS ATTACHED TO THE PISTOL GRIP. IT WAS NOT USED DURING THE PROCEDURE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876831 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, AN INSERTER BROKE IN THE OPAL PLACER IMPLANT HOLDER. THE OPAL IMPLANT HOLDER STRAIGHT AND OPAL IMPLANT HOLDER PISTOL GRIP, THESE BOTH PARTS USE THIS INNER HOLDER PART THAT BROKE. BOTH PIECES WERE RECOVERED, SMALL PIECES AND THE MAIN PIECE. THE SECOND SET WAS AVAILABLE TO COMPLETE THE PROCEDURE, THE SURGEON WAS ABLE TO REACH OUT TO SURGERY WITHIN ABOUT FIVE TO TEN (5-10) SECONDS. THERE WAS A FIVE TO TEN (5-10) SECONDS DELAY IN THE SURGERY. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED SAFELY AND SUCCESSFULLY. CONCOMITANT MEDICAL DEVICES: UNK - CAGE/SPACERS: OPAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) . THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670969 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, AN INSERTER BROKE IN THE OPAL PLACER IMPLANT HOLDER. THE OPAL IMPLANT HOLDER STRAIGHT AND OPAL IMPLANT HOLDER PISTOL GRIP, THESE BOTH PARTS USE THIS INNER HOLDER PART THAT BROKE. BOTH PIECES WERE RECOVERED, SMALL PIECES AND THE MAIN PIECE. THE SECOND SET WAS AVAILABLE TO COMPLETE THE PROCEDURE, THE SURGEON WAS ABLE TO REACH OUT TO SURGERY WITHIN ABOUT FIVE TO TEN (5-10) SECONDS. THERE WAS A FIVE TO TEN (5-10) SECONDS DELAY IN THE SURGERY. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED SAFELY AND SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNK - CAGE/SPACERS: OPAL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN).  THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER STRAIGHT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670933 ↗
• InjuryFeb 4, 2019Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN L4-5 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), THE SURGEON HAD NOTICED AN INCREASED BLEEDING WHILE WORKING IN THE INTERBODY SPACE. THE PEDICLE SCREWS ON THE CONTRALATERAL SIDE HAS BEEN PLACED AND THE SCREW HOLES WERE MADE ON THE IPSILATERAL (SAME) SIDE OF THE TLIF BUT HAD NOT BEEN PUT IN YET. THE SURGEON NOTICED A SIGNIFICANT AMOUNT OF BLEEDING WHILE USING THE MEDTRONIC NAVIGATION PROBE IN THE DISC SPACE. IT WAS CONTROLLED BUT OOZING DURING THE ENTIRE PORTION OF THE CASE. THE PROBE HAS BROKEN THROUGH THE ANTERIOR PORTION OF THE DISC SPACE WHICH COULD HAVE LED TO THE BLEEDING. AN OPAL CAGE WAS PLACED BY THE SURGEON, A ROD THEN PLACED ON THE SAME SIDE, AND THEN THEY SPUN THE O-ARM WHICH IS A 3D IMAGE OF THE SPINE. THE LATERAL IMAGE CONFIRMED THAT THE SURGEON PLACED THE CAGE TOO FAR ANTERIOR IN THE DISC SPACE SO HE ATTEMPTED TO REMOVE THE CAGE POSTERIORLY. AS HE ATTEMPTED THIS, HE NOTICED INCREASED BLOOD LOSS SO HE DECIDED TO CALL A VASCULAR SURGEON TO COME IN TO ASSIST. THE PATIENT WAS CLOSED FROM THE BACK, THEN FLIPPED SUPINE, AND THE VASCULAR SURGEONS ACCESSED THE SPINE ANTERIORLY TO SEE WHAT WAS CAUSING THE BLE

  Patient problems: No Code Available

  MAUDE report 8302314 ↗
• MalfunctionFeb 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, AN OPAL SPACER APPEARED TO BREAK DURING INSERTION. THIS OCCURRED AT LEVELS L5-S1 WITH THE USE OF AN PISTOL GRIP INSERTER DURING ROTATION INTO IT'S FINAL POSITION USING THE RECOMMENDED TECHNIQUE. SURGICAL PROCEDURE WAS A L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). ALL FRAGMENTS GENERATED WERE EASILY RETRIEVED WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER OPAL SPACER. NO HARM CAME TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: PISTOL GRIP INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPAL SPACER 10MM X 24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297587 ↗
• MalfunctionJan 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE SCREW THAT WAS PART OF THE OPAL IMPLANT HOLDER FELL OUT. A SECOND IMPLANT HOLDER WAS AVAILABLE TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH APPROXIMATELY 10 MINUTES SURGICAL DELAY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281886 ↗

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