N/A 8670001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902293115), received between Oct 26, 2020 and Apr 27, 2022 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Break; Mechanical Jam; Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T12BKP, T10, 11, 12, L1 POSTERIOR FIXATION FOR OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT AFTER THE BKP PROCEDURE, WHEN INSERTING A SCREW INTO THE AFFECTED VERTEBRA, A GUIDEWIRE WAS INSERTED. AFTER INSERTING THE SCREW, THE GUIDEWIRE COULD NOT BE REMOVED. THE SCREW WAS REMOVED AND THE GUIDEWIRE WAS CUT. 20 MM TIP OF GUIDEWIRE REMAINS IN THE CEMENT INSIDE THE VERTEBRAL BODY. THERE WAS A DELAY IN PROCEDURE BUT LESS THAN 60 MINUTES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT IS STILL IN USE AND NOT RETURNING FOR ANALYSIS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14217224 ↗
• InjuryDec 22, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS-ADULT SPINAL DEFORMITY INVOLVED IN THE POSTERIOR SPINAL CORRECTION FUSION PROCEDURE. LEVELS IMPLANTED- T11-IL. IT WAS REPORTED THAT THE GUIDE WIRE GOT STUCK IN THE HOLLOW PART OF THE SCREW AND WHEN REMOVING IT, THE SCREW WAS REMOVED TOGETHER. IN THE S2 SACRAL FORAMEN PART, SCREW INSERTION MARK WAS FORMED. IN AN ADDITIONAL SURGERY THE SURGICAL PROCEDURE WAS CHANGED FROM S2AI TO ILIAC SCREW DURING THE SAME DAY. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. PRODUCT USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057970 ↗
• MalfunctionAug 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR REVISION SURGERY DUE TO RIGHT L5 SCREW WAS PLACED IN THE SPINAL CANAL. IT WAS REPORTED THAT ON (B)(6) 2021, L3-5 PLIF WAS PERFORMED, THE RIGHT L5 SCREW WAS PLACED IN THE SPINAL CANAL. ALTHOUGH THERE WAS NO NEUROLOGICAL SYMPTOM, REOPERATION WAS PERFORMED HASTILY, THE SCREW WAS REMOVED AND THEN REINSERTED. AFTER REMOVING THE SCREW INSERTED IN L5, A PILOT HOLE WAS CREATED AGAIN FOR SCREW PLACEMENT. THE SITUATION WAS THE SAME AT THE TIME OF THE INITIAL OPERATION THAT THE PATIENT'S PEDICLE AND VERTEBRAL BODY WERE VERY HARD AND DIFFICULT TO INSERT. THE FIRST TIME THEY REINSERTED IT, THE SCREW CAME OFF TO THE LATERAL, AND THE SCREW WAS REMOVED AGAIN (THE SCREW WAS ALSO NOT TIGHT). SINCE THE F7.5 X 45 MM SCREW WAS USED, F6.5 MM TAP WAS PERFORMED THROUGH THE GUIDE WIRE AFTER CREATING THE PILOT HOLE. IN THE SECOND REINSERTION, THE GUIDE WIRE WAS INSERTED WHEN THE INSERTION WAS CONFIRMED WITH PROBE ABOUT 10 MM FROM THE POSTERIOR WALL OF THE VERTEBRAL BODY. THE GUIDE WIRE WAS INSERTED ONLY ABOUT 15 MM FROM THE POSTERIOR WALL OF THE VERTEBRAL BODY. SINCE IT WAS STIFF WHEN PERFORMING

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12329554 ↗
• MalfunctionAug 16, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBER OF THE REPORTED PRODUCT IS KH20G652.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12323353 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOSIS THESIS INVOLVED IN OLIF+PPS PROCEDURE USED IN SPINAL THERAPY. LEVELS IMPLANTED: L4/5. IT WAS REPORTED DURING USE, SUPERIOR ADJACENT SEGMENT DISEASE IN PATIENT WAS REPORTED. THERE WAS NO MALFUNCTION OF THE PRODUCT REPORTED. THE BONE WAS FRAGILE ORIGINALLY BECAUSE OF STEROIDS, RHEUMATISM OR DIALYSIS. REMOVAL OF ROD AND SET SCREW WAS PLANNED ON (B)(6) 2020. THERE WAS NO PLAN TO REMOVE CAGE IN REVISION SURGERY. QUANTITY-2 SCREWS WERE REMOVED ON L5, BUT LOT# IS UNKNOWN. THERE WAS NO MALFUNCTION OF IMPLANTED PRODUCTS. OLIF WAS PERFORMED ON L4/5, POSTERIOR SENTANT WAS PERFORMED. DUE TO ADJACENT SEGMENT DISEASE ON L3/4, IT WAS PLANNED TO PERFORM OLIF ON L3/4 AND INSERT PPS IN L3 AND PERFORM CONNECTION ON L3-5 ON (B)(6). ADDITIONAL INFORMATION REGARDING THE RE-OPERATION: BONE FUSION WAS ACHIEVED COMPLETELY ON L4/5, SCREW ON L5 WAS REMOVED. OLIF WAS PERFORMED BETWEEN L3/4, POSTERIOR FUSION ON L3/4 WITH PPS WAS PERFORMED AND THE OPERATION WAS COMPLETED. PATIENT STATUS IS UNKNOWN, BUT MOVEMENT OF LEG RIGHT AFTER THE OPERATION WAS WELL.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10733764 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOLIS THESIS INVOLVED IN OLIF+PPS PROCEDURE USED IN SPINAL THERAPY. LEVELS IMPLANTED: L4/5. IT WAS REPORTED DURING USE, SUPERIOR ADJACENT SEGMENT DISEASE IN PATIENT WAS REPORTED. THERE WAS NO MALFUNCTION OF THE PRODUCT REPORTED. THE BONE WAS FRAGILE ORIGINALLY BECAUSE OF STEROIDS, RHEUMATISM OR DIALYSIS. REMOVAL OF ROD AND SET SCREW WAS PLANNED ON (B)(6) 2020. THERE WAS NO PLAN TO REMOVE CAGE IN REVISION SURGERY. QUANTITY-2 SCREWS WERE REMOVED ON L5, BUT LOT# IS UNKNOWN. THERE WAS NO MALFUNCTION OF IMPLANTED PRODUCTS. OLIF WAS PERFORMED ON L4/5, POSTERIOR SENTANT WAS PERFORMED. DUE TO ADJACENT SEGMENT DISEASE ON L3/4, IT WAS PLANNED TO PERFORM OLIF ON L3/4 AND INSERT PPS IN L3 AND PERFORM CONNECTION ON L3-5 ON (B)(6). ADDITIONAL INFORMATION REGARDING THE RE-OPERATION: BONE FUSION WAS ACHIEVED COMPLETELY ON L4/5, SCREW ON L5 WAS REMOVED. OLIF WAS PERFORMED BETWEEN L3/4, POSTERIOR FUSION ON L3/4 WITH PPS WAS PERFORMED AND THE OPERATION WAS COMPLETED. PATIENT STATUS IS UNKNOWN, BUT MOVEMENT OF LEG RIGHT AFTER THE OPERATION WAS WELL.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10733721 ↗