MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; SPINE SURGERY

Model Number SY001TS

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with sy001ts - ennovate set screw sterile.According to the complaint description, the patient reported persistent pain.The initial procedure had been performed on (b)(6) 2021 with l4-l5-s1 fixation and satisfactory evolution.The pain started postoperatively on approximately (b)(6) 2022.Results of x-rays showed the lock nut seemed to be completely loose.The patient underwent re-operation at another hospital.A revision surgery was necessary.Additional information was not provided.The adverse event / malfunction is filed under aag reference xc (b)(4).Associated medwatch reports: 400579314 (9610612-2022-00367) sy001ts, 400580373 (9610612-2022-00371) sy001ts.Involved components: 400580374 - sy843ts - lot 52704703, 400580375 - sy835ts - lot 52722372, 400580376 - sy855ts - lot 52683304, 400580377 - sy852ts - lot 52619685, 400580378 - sy844ts - lot 52701068, 400580381 - sy845ts - lot 52701074, 400580382 - sy834ts - lot 52715469, 400580383 - sy437ts - lot 52666147, 400580384 - sy437ts - lot 52697467.

Event Description

Associated medwatch reports: 400579314 (9610612-2022-00367) sy001ts.400580372 (9610612-2022-00370) sy001ts.400580373 (9610612-2022-00371) sy001ts.Involved components: 400580374 - sy843ts -ennovate polyax.Screw 7.5x40mm fenestr.- lot 52704703.400580375 - sy835ts - ennovate polyax.Screw 6.5x50mm fenestr.- lot 52722372.400580376 - sy855ts - ennovate polyax.Screw 6.5x50mm fenestr.- lot 52683304.400580377 - sy852ts - ennovate polyax.Screw 8.5x35mm fenestr.- lot 52619685.400580378 - sy844ts - ennovate polyax.Screw 7.5x45mm fenestr.- lot 52701068.400580381 - sy845ts - ennovate polyax.Screw 7.5x50mm fenestr.- lot 52701074.400580382 - sy834ts - ennovate polyax.Screw 6.5x45mm fenestr.- lot 52715469.400580383 - sy437ts - ennovate curved rod 5.5x70mm - lot 52666147.400580384 - sy437ts - ennovate curved rod 5.5x70mm - lot 52697467.

Manufacturer Narrative

Additional information: a1- patient identifier.A2- patient age.A3- patient sex.H6- codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Due to a lack of the products, an investigation is not possible.Mri-pictures have been provided.At least one loosened set screw can be confirmed.However, an investigation in regards to the root cause of this occurrence is not possible on the basis of the pictures.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.There is one similar complaint against lot number: 52720732 and 52718330, from the same hospital.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability 1(5) of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15988997
• MDR Text Key: 305541475
• Report Number: 9610612-2022-00370
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY001TS
• Device Catalogue Number: SY001TS
• Device Lot Number: 52724161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SY437TS - LOT 52666147.; SY437TS - LOT 52666147.; SY437TS - LOT 52697467.; SY437TS - LOT 52697467.; SY834TS - LOT 52715469.; SY834TS - LOT 52715469.; SY835TS - LOT 52722372.; SY835TS - LOT 52722372.; SY843TS - LOT 52704703.; SY843TS - LOT 52704703.; SY844TS - LOT 52701068.; SY844TS - LOT 52701068.; SY845TS - LOT 52701074.; SY845TS - LOT 52701074.; SY852TS - LOT 52619685.; SY852TS - LOT 52619685.; SY855TS - LOT 52683304.; SY855TS - LOT 52683304.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male