OPAL 03.803.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034722443), received between Oct 2, 2018 and Sep 9, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A SPINAL SURGERY AN OPAL IMPLANT HOLDER, STRAIGHT AND AN OPAL IMPLANT HOLDER, PISTOL GRIP BROKE. DURING THE OPERATION, THE SURGEON FLIPPED THE CAGE WITH EXCESSIVE FORCE CAUSING THE FRONT OF THE CAGE HOLDER TO BREAK. IT FELL INTO THE PATIENT'S BODY. THE SURGEON TRIED TO REMOVE THE FRACTURE TOOL BUT WAS NOT ABLE TO RETRIEVE IT; THE CURRENT FRACTURE TOOL REMAINS IN THE PATIENT'S BODY. PATIENT OUTCOME WAS UNKNOWN. IT WAS NOTED THE SURGEON WAS USING A LARGE CAGE IN A SMALL DISC SPACE. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES IT WAS IDENTIFIED THAT TWO (2) OF THE BROKEN OPAL IMPLANT HOLDERS, STRAIGHT WERE RETURNED. THIS REPORT IS FOR AN OPAL IMPLANT HOLDER, STRAIGHT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8062066 ↗
• MalfunctionOct 8, 2018Misassembly by Users; Misassembly by Users

  IT WAS FURTHER REPORTED THAT THE DEVICE IS NOW WORKING FINE AND THAT THE SURGEON AND OR STAFF HAD INADVERTENTLY OVERTIGHTENED THE DEVICE WHILE TRYING TO LOOSEN THE KNOB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943128 ↗
• InjuryOct 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A SPINAL SURGERY AN OPAL IMPLANT HOLDER, STRAIGHT AND AN OPAL IMPLANT HOLDER, PISTOL GRIP BROKE. DURING THE OPERATION, THE SURGEON FLIPPED THE CAGE WITH EXCESSIVE FORCE CAUSING THE FRONT OF THE CAGE HOLDER TO BREAK. IT FELL INTO THE PATIENT'S BODY. THE SURGEON TRIED TO REMOVE THE FRACTURE TOOL BUT WAS NOT ABLE TO RETRIEVE IT; THE CURRENT FRACTURE TOOL REMAINS IN THE PATIENT'S BODY. PATIENT OUTCOME WAS UNKNOWN. IT WAS NOTED THE SURGEON WAS USING A LARGE CAGE IN A SMALL DISC SPACE. THIS REPORT IS FOR AN OPAL IMPLANT HOLDER, STRAIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7929845 ↗
• MalfunctionOct 2, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L3/4 AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) FOR L4/5 ON (B)(6) 2018. DURING THE PLIF SURGERY, TWO (2) PIECES OF UNKNOWN CAGES FOR L4/5 WERE IMPLANTED USING THE OBLIQUE POSTERIOR ATRAUMATIC LUMBAR (OPAL) IMPLANT HOLDER PISTOL GRIP. AFTER THE IMPLANTATION THE LOCK OR RELEASE KNOB BECAME STUCK. THE SURGEON THEN USED AN OPAL IMPLANT HOLDER-STRAIGHT TO IMPLANT ONE (1) UNKNOWN CAGE FOR L3/4 VIA TRANSFORAMINAL LUMBAR INTERBODY FUSION. AN X-RAY WAS PERFORMED INTRA-OPERATIVELY AND SHOWED THAT TWO (2) CAGES OF L4/5 WERE OUT OF POSITION. THE SURGEON TRIED TO USE THE OPAL IMPLANT HOLDER-STRAIGHT TO CORRECT THE CAGE POSITION BUT THE LOCK OR RELEASE KNOB BECAME STUCK. THE SURGEON QUICKLY REPAIRED THE OPAL IMPLANT HOLDER-STRAIGHT AND USED IT TO CORRECT THE CAGE POSITION. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A 45-MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER STRAIGHT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927410 ↗