N/A 8670010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902756351), received between Oct 26, 2020 and Oct 26, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 10733858 ↗
• 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 10733802 ↗