OPAL 03.803.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034722450), received between Sep 1, 2017 and Jun 27, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 19 most recent of 19 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON L4-L5, THE SURGEON REQUESTED AN OPAL CAGE AND THE SURGICAL TECHNICIAN LOADED IMPLANT PROPERLY ONTO THE OPAL IMPLANT HOLDER PISTOL GRIP. JUST BEFORE THE SURGEON WAS GOING TO IMPLANT IT WAS NOTICED THAT SOMETHING IS DIFFERENT ABOUT THE HOLDER AND THE DISTAL END WAS BROKEN OFF OF THE IMPLANT HOLDER. FRAGMENT DID NOT GO INTO THE WOUND AND IT WAS RETRIEVED. SURGEON DETACHED THE IMPLANT AND ANOTHER OPAL INSERTER WAS USED AND PROCEEDED AS PLANNED. THERE WAS A SURGICAL DELAY OF 2 MINUTES. NO HARM TO THE PATIENT AND NO FURTHER ISSUE. CONCOMITANT DEVICE REPORTED: OPAL SPACER (PART # 08.803.053, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196746 ↗
• MalfunctionDec 21, 2018Break; Break

  IT WAS NOTED THE PROCEDURE WAS BEING PERFORMED TO FIX L4/5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188998 ↗
• MalfunctionDec 10, 2018Break; Break

  CONCOMITANT DEVICE REPORTED: UNKNOWN CAGE/SPACERS: OPAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147836 ↗
• MalfunctionOct 11, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, AFTER ANTERIOR AND POSTERIOR (A & P) LUMBAR FUSION PROCEDURE, THE NURSE NOTICED THE TWO PARTS THAT CONSTITUENT THE INSERTER OF THE OPAL IMPLANT HOLDER WITH PISTOL GRIP DID NOT DISASSEMBLE. IT WAS ASSEMBLED DURING THE PROCEDURE BUT WAS NOT IN USE. THE PROBLEM OCCURRED WHEN TRYING TO DISASSEMBLE THE DEVICE WAS AFTER THE SURGERY. NO SURGICAL DELAY WAS CAUSED. THERE WERE NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7957160 ↗
• InjuryOct 3, 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. THIS REPORT IS FOR AN OPAL IMPLANT HOLDER, PISTOL GRIP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7929857 ↗
• 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 PISTOL GRIP. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927578 ↗
• 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 PISTOL GRIP. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927409 ↗
• MalfunctionJul 5, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2018, THE POSTERIOR SPINE FUSION SURGERY WAS PERFORMED FOR DEGENERATIVE LUMBAR SCOLIOSIS BY USING THE OBLIQUE POSTERIOR ATRAUMATIC LUMBAR (OPAL) SYSTEM. WHILE ATTEMPTING TO INSERT A CAGE MORE DEEPLY, THE SURGEON TRIED TO ROTATE THE REPORTED DEVICE OPAL IMPLANT HOLDER, W/PISTOL GRIP, 90° CLOCKWISE A COUPLE OF TIMES. THEN, THE KNOB MOVED TO ¿RELEASE¿ FROM ¿HOLD¿ POSITION AND THE CAGE CAME OFF THE DEVICE. AGAIN, HE TRIED TO HOLD THE CAGE WITH THE SAME DEVICE WHILE THE CAGE WAS SITTING IN THE PATIENT¿S BODY, BUT THE GRIP DID NOT MOVE FROM ¿RELEASE¿ POSITION. FINALLY, HE USED A DIFFERENT OPAL IMPLANT HOLDER AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURES. THE SURGERY WAS DELAYED ABOUT THIRTY (30) MINUTES AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AFTER THE SURGERY, THEY TRIED AGAIN TO ROTATE THE GRIP BUT THE GRIP WAS STILL STUCK. CONCOMITANT DEVICE: OPAL CAGE (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664332 ↗
• MalfunctionMar 12, 2018Device Operational Issue; Device Operational Issue

  SERVICE AND REPAIR REPORTED THAT THE HANDLE OF THE OPAL IMPLANT HOLDER PISTOL GRIP DEVICE CAME OFF OF THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331545 ↗
• MalfunctionJan 19, 2018Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF THE SET EVALUATION TECHNICIAN FOUND THAT AN OPAL IMPLANT HOLDER WAS BROKEN. THERE IS NO PATIENT OR PROCEDURE INVOLVED SINCE THE DEVICE WAS NEVER USED FOR SURGERY. THIS REPORT IS FOR ONE (1) OPAL IMPLANT HOLDER PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7207396 ↗
• MalfunctionNov 9, 2017Bent; Bent

  IT WAS REPORTED THAT AN OPAL IMPLANT HOLDER TIP WOULD NOT ATTACH PROPERLY TO AN OPAL SPACER DURING A L4-S1 INITIAL TRANFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2017. THE IMPLANT HOLDER APPEARED TO BE BENT ON ONE OF THE SIDE ARMS. THERE WAS NO REPORTED SURGICAL DELAY. THERE WAS A BACK-UP INSTRUMENT AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES ONE DEVICE CONCOMITANT DEVICE: OPAL SPACER IMPLANT (PART 08.803.052, LOT UNKNOWN, QTY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7016248 ↗
• MalfunctionOct 23, 2017Break; Unintended Movement; Break; Unintended Movement

  THE SERVICE AND REPAIRS DEPARTMENT DOCUMENTED THAT AN OPAL IMPLANT HOLDER PISTOL GRIP HANDLE IS BROKEN. ISSUE FOUND DURING INSPECTION OF SET. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6970437 ↗
• MalfunctionSep 1, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE HANDLE OF AN OPAL IMPLANT HOLDER PISTOL GRIP IS LOOSE. THE DEVICE HAS A ¿WAGGLE¿ TO THE HANDLE. THIS WAS NOTICED WHILE THE INSTRUMENT WAS BEING PUT BACK INTO A SET, AFTER GOING THROUGH STERILE PROCESSING. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6839713 ↗