ENNOVATERecalls & reported problems across all models
Aesculap AG · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ENNOVATE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 3
We found 11 models of ENNOVATE by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2020 and Jan 10, 2022 — classified as 14 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).
3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ENNOVATE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 ↗
- Nov 18, 2020Terminated
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
Z-1429-2022 · Root cause: Component design/selection · Recall details · FDA record ↗
- Jul 13, 2020Terminated
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
Z-1428-2022 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported ENNOVATE problems
Device problems
- Detachment of Device or Device Component4
- Device Damaged by Another Device4
- Material Fragmentation3
- Break1
- Connection Problem1
- Degraded1
- Device Dislodged or Dislocated1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- Foreign Body In Patient1
- Implant Pain1
- Insufficient Information1
- Joint Laxity1
- No Known Impact Or Consequence To Patient1
ENNOVATE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENNOVATE SZ380RORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 recalls0 reports
- ENNOVATE SY001TSThoracolumbosacral pedicle screw system1 recall4 reports
- ENNOVATE SZ378RORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- ENNOVATE SZ282RORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ENNOVATE SZ228RWRENCH1 report
- ENNOVATE SZ277RORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ENNOVATE SZ405RORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ENNOVATE SY645TSThoracolumbosacral pedicle screw system1 report
- ENNOVATE SY647TSThoracolumbosacral pedicle screw system1 report
- ENNOVATE SY135TSThoracolumbosacral pedicle screw system1 report
- ENNOVATE SX950TSThoracolumbosacral pedicle screw system1 report
Recent ENNOVATE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 10, 2022Device Damaged by Another Device; Difficult to Open or Close; Device Damaged by Another Device; Difficult to Open or Close
IT WAS REPORTED TO AESCULAP AG THAT AN ENNOVATE ROD PERSUADER (PART # SZ277R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE INSTRUMENT WAS NOT ABLE TO BE OPENED AND IT JAMMED WITH THE SCREW HEAD. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13213657 ↗InjuryNov 7, 2021Material Separation; Material Separation
IT WAS REPORTED TO AESCULAP AG THAT A SZ405R-ENNOVATE FRI DOWNTUBE SHORT (PART # SZ405R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS OR PROBLEMS. AFTER THE OPERATION, THE SURGEON DISCONNECTED THE TUBES, ACCORDING TO THE SURGICAL PROCEDURE USING THE SZ380R INSTRUMENT. DURING THE FOLLOW-UP X-RAY EXAMINATION, A BROKEN PIECE FROM THE SZ405R INSTRUMENT WAS IDENTIFIED IN THE PATIENT. REOPERATION WAS PERFORMED AND THE PART WAS REMOVED. THE PATIENT WAS NOT INJURED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 12760394 ↗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 ↗MalfunctionSep 17, 2021Device Damaged by Another Device; Device Damaged by Another Device
UPDATE: THE PROCEDURE WAS A POSTERIOR LUMBAR INTERBODY FUSION (PLIF).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12489104 ↗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 ↗InjuryJul 12, 2021Break; Break
UPDATE: ADDITIONAL INFORMATION RECEIVED. PATIENT HARM CHANGED FROM SURGERY DELAY TO ADDTIONAL MEDICAL INTERVENTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12150049 ↗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 ↗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 ↗InjuryApr 6, 2021Product Quality Problem; Connection Problem; Product Quality Problem; Connection Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SX950TS - ENNOVATE TRANSCONNECTOR 50-60MM STERILE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CONNECTION OF THE DEVICE WAS NOT POSSIBLE. EVEN AFTER SEVERAL ATTEMPTS, THE SURGEON DID NOT MANAGE TO FIX THE CROSS CONNECTOR WITH THE RODS. THE SCREW ALWAYS OVERTIGHTENED. THERE WAS ANOTHER IMPLANT AVAILABLE. SURGERY DELAY WAS EXTENDED BY APPROX. 30 MIN. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. 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 11619048 ↗MalfunctionMar 25, 2021Degraded; Degraded
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SZ228R - ENNOVATE TORQUE WRENCH HANDLE 10NM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CENTRAL PROCESSING DEPARTMENT (CPD) STAFF WAS PROCESSING THE TRAY TO BE READY FOR SURGERY AND UPON INSPECTION, METAL SHAVINGS FELL OUT OF THE INSTRUMENT. INSTRUMENT HAS BEEN PULLED AND SWAPPED OUT OF THE SET WITH THE REPLACEMENTS. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11568438 ↗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 ↗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 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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