N/A 9339040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902692604), received between Mar 22, 2021 and Mar 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS-T9-T10 INFECTION INVOLVED IN THORACIC CORPECTOMY PROCEDURE. LEVELS IMPLANTED- T9. IT WAS REPORTED THAT DURING PROCEDURE, THE SCREWDRIVER WAS ¿STRIPPED¿, WOULD NOT HOLD SCREW. INSTRUMENT DID NOT BROKE, DEFORMED TIP (STRIPPED) HEX DRIVER TIP. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. ON 2021-MAR-08, RECEIVED ADDITIONAL INFORMATION THAT INITIAL SURGERY WAS PERFORMED WITH ORIGINAL PRODUCTS, BUT NOT COMPLETED. ON (B)(6) 2021, PATIENT RETURNED FOR ADDITIONAL SURGERY, INCLUSIVE OF ADDITIONAL TREATMENT TO COMPLETE SURGERY FROM (B)(6) 2021. THE SURGERY ON (B)(6) 2021 WAS DELAYED WHILE THEY TRIED TO LOCK THE VANTAGE PLATE. APPROXIMATE DELAY WAS 30-45 MINUTES. NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543577 ↗
• InjuryMar 22, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS-T9-T10 INFECTION INVOLVED IN THORACIC CORPECTOMY PROCEDURE. LEVELS IMPLANTED- T9. IT WAS REPORTED THAT DURING PROCEDURE, THE SCREWDRIVER WAS ¿STRIPPED¿, WOULD NOT HOLD SCREW. INSTRUMENT DID NOT BROKE, DEFORMED TIP (STRIPPED) HEX DRIVER TIP. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. ON 2021-MAR-08, RECEIVED ADDITIONAL INFORMATION THAT INITIAL SURGERY WAS PERFORMED WITH ORIGINAL PRODUCTS, BUT NOT COMPLETED. ON (B)(6) 2021, PATIENT RETURNED FOR ADDITIONAL SURGERY, INCLUSIVE OF ADDITIONAL TREATMENT TO COMPLETE SURGERY FROM(B)(6) 2021 . THE SURGERY ON (B)(6) 2021 WAS DELAYED WHILE THEY TRIED TO LOCK THE VANTAGE PLATE. APPROXIMATE DELAY WAS 30-45 MINUTES. NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543544 ↗