ENNOVATE SZ378RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964719561), received between Sep 4, 2020 and Sep 30, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• InjurySep 30, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SZ378R - ENNOVATE MIS DOWNTUBE SHORT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE RETAINING TABS ARE BROKEN. THE BROKEN PIECES WERE RETRIEVED & DISCARDED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00360 (400510390 - SZ378R).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555439 ↗
• InjuryApr 16, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN ENNOVATE MIS DOWNTUBE SHORT (PART # SZ378R) WAS USED DURING A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGICAL PROCEDURE, THE ATTACHMENT MECHANISM OF THE DEVICE DISLODGED AND STUCK TO THE PEDICLE SCREW. AN X-RAY WAS PERFORMED TO CONFIRM THE PART LOCATION, AND THEN THE SURGEON RETRIEVED THE FRAGMENT FROM THE PATIENT. A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE INTERVENTION PERFORMED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC (B)(4); CC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682152 ↗
• InjuryApr 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SZ378R - ENNOVATE MIS DOWNTUBE SHORT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE MECHANISM DISLODGED DURING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. ATTACHMENT MECHANISM OF THE DOWNTUBE DISLODGED AND STUCK TO THE PEDICLE SCREW, SURGEON REQUIRED ADDITIONAL INTERVENTION TO REMOVE THE PART (X-RAY AND PIECE RETRIEVAL). AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THERE WAS A DELAY OF 10 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629030 ↗
• InjuryMar 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP INC. THAT A ENNOVATE MIS DOWNTUBE SHORT (PART # SZ378R) WAS USED DURING A MINIMALLY INVASIVE SPINE (MIS) FIXATION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ASSISTANT OVER ROTATED THE DOWN-TUBE REMOVAL KEY, WHICH LEFT THE TIP STILL SLIGHTLY IN THE SCREW. REPORTEDLY, THE TIP DETACHED, AFTER ROCKING AND TWISTING THE TUBE. THE LOOSE TIP WAS RETRIEVED FROM THE PROXIMAL AREA OF THE WOUND. THE WOUND WAS IRRIGATED, AND THEN VISUALLY INSPECTED. ADDITIONALLY, THE USER STATED THAT THE FIRST GENERATION DOWNTUBE REMOVAL KEY WAS USED. THE ACCOUNT HAS SINCE BEEN TRAINED AND SWITCHED OVER TO THE NEWER VERSION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 5-7 MINUTES. THE PATIENT WAS UNDER ANESTHESIA. THE FINAL OUTCOME WAS NOT AFFECTED BY THE EVENT. THE ADVERSE EVENT / MALFUNCTION WAS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474643 ↗
• InjuryMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO CHANGES REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457272 ↗
• MalfunctionSep 4, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A ENNOVATE MIS DOWNTUBE. ACCORDING TO THE COMPLAINT DESCRIPTION THE RETAINING LUG IS BROKEN OFF INTRAOPERATIVELY BUT DID NOT REMAIN IN SITU. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10495986 ↗