ENNOVATE SY001TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964989728), received between Mar 18, 2021 and Aug 5, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 15, 2022Open, Classified

   Potential for the incorrect screw to be included in the package.

   Z-1638-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED TO AESCULAP AG THAT TWO (2) ENNOVATE SET SCREWS (PART # SY001TS) WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SET SCREW WAS DAMAGED WHILE FASTENING WITH A PARSUADER. A NEW ENNOVATE SET SCREW (REF. MDR ID 9610612-2021-00532) WAS USED, BUT THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED USING A THIRD SCREW. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00532_MDR (400520951 + SY001TS). INVOLVED COMPONENTS: SY632TS - ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED - 52534620.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284282 ↗
• MalfunctionAug 5, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED TO AESCULAP (B)(4) THAT TWO (2) ENNOVATE SET SCREWS (PART # SY001TS) WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SET SCREW (REF. MDR ID 9610612-2021-00531) WAS DAMAGED WHILE FASTENING WITH A PARSUADER. A NEW ENNOVATE SET SCREW WAS USED, BUT THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED USING A THIRD SCREW. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00531_MDR (B)(4). INVOLVED COMPONENTS: SY632TS - ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED - 52534620.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284280 ↗
• InjuryJun 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ENNOVATE SET SCREW STERILE - SY001TS. ACCORDING TO THE COMPLAINT DESCRIPTION, AFTER AN OPEN ENNOVATE IMPLANTATION PROCEDURE AT THE END OF 2020, A SCREW LOOSENING WITH LOSS OF THE LOCKING NUT OCCURRED. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00433 ((B)(4)+ SY001TS), 9610612-2021-00435 ((B)(4) + SY001TS), 9610612-2021-00424 ((B)(4)+ SY001TS. INVOLVED COMPONENTS: SY658TS - ENNOVATE POLYAX.SCREW 8.5X70MM CANULATED - 52383818, SY655TS - ENNOVATE POLYAX.SCREW 8.5X50MM CANULATED - 52383871, SY706TS - ENNOVATE CLOSED/OPEN DOMINO CONNECT.11MM - 52446745, SY415TS - ENNOVATE STRAIGHT ROD 5.5X150MM - 52473694, AE-QAS-SP41 - COLLECT.NO.QAS SPINE POSTERIOR STABILIS. - BATCH UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11922846 ↗
• InjuryMar 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP (B)(4) THAT A THAT AN ENNOVATE SET SCREW STERILE (PART # SY001TS) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, FOUR (4) WEEKS POST SURGERY, A REVISION WAS NECESSARY DUE TO LOOSENING OF THE SCREWS. REPORTEDLY, THE REVISION SURGERY WAS REQUIRED DUE TO TWO (2) LOCKING SCREWS OF THE ENNOVATE SYSTEM HAVING BECOME COMPLETELY SEPARATED THE PATIENT HAD MACS AND HYDROLIFT IMPLANTED. ADDITIONALLY, DURING SURGERY A THIRD SCREW WAS FOUND TO HAVE LOOSENED, BUT NOT SEPARATED. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: SY745TS - ENNOVATE MONOAX. SCREW 7.5X50MM FENESTR. - LOT 52628861, SY745TS - ENNOVATE MONOAX. SCREW 7.5X50MM FENESTR. - LOT 52443787, SY745TS - ENNOVATE MONOAX. SCREW 7.5X50MM FENESTR. - LOT 52484182, SY910TS - ENNOVATE MIS STRAIGHT ROD 5.5X100MM. - LOT 52619283.

  Patient problems: Failure of Implant

  MAUDE report 11517323 ↗