MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES; IMPLANTS SPINAL MOTION

Model Number	SW996K
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: a batch-related review of the complaint history was not possible, as the product and batch number are unknown.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.
Event or Problem Description
It was reported to aesculap inc., via the annual activl enhanced safety surveillance study (ess) covering a reporting period from 01feb2021 to 31jan2022, that an unknown activ l device was implanted.According to the complainant, the patient experienced a postoperative "sensory neurological safety event." the initial surgery occurred on an unspecifed date.The patient had been treated at the l5-s1 level with the spike endplate.The patient developed bilateral pars fractures 10 months after having the arthroplasty device implanted.A permanent impairment occurred.Additional patient information is not available, although it had been requested.The adverse event / malfunction is filed under aic reference xc 100031157 / 400562858.Associated medwatch reports: 2916714-2022-00077 (400562857 - ae-qas-sp42) ; 2916714-2022-00079 (400562859 - ae-qas-sp42).
Event or Problem Description
Update: an activl ess adverse event form was received with the following data: original implantation date was 19may2020 for "chronic back and right leg" in the index level l5-s1.Bone was was not used during surgery, and estimated percentage of endplate coverage was 85-90%.Non-steriodal anti-inflammatory drugs (nsaids) were not used after the procedure.The adverse event onset date for chronic pain was 02aug2021.There was development of bilateral pars fractures at approximately 14 months after surgery.Serial computed tomography (ct) scan results demonstrated the fractures developed at that time interval.Medications and injections were given for pain management.The patient has sought multiple surgical opinions, and has opted for conservative management.Management of condition includes medications and activity modification.The outcome is noted as not recovered/not resolved.The adverse event / malfunction is filed under aic reference xc 100031157 / 400562858.Leading materials were also updated for superior endplate, inferior endplate, and inlay: associated medwatch reports: 2916714-2022-00077 ((b)(4) - sw992k).2916714-2022-00078 ((b)(4) - sw996k).2916714-2022-00079 ((b)(4) - sw965).
Additional Manufacturer Narrative
Additional information/correction: a - patient data b5 - update to description.B6- tests.B7- relevant patient history.D1 - d2 - suspect medical device.D4 - product code, lot number, expiration date.F9 - approximate age of device.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: a batch-related review of the complaint history was not possible, as the product and batch number are unknown.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: ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES
• Common Device Name: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15201558
• Report Number: 2916714-2022-00078
• Device Sequence Number: 6413192
• Product Code: MJO
• UDI-Device Identifier: 04046963143862
• UDI-Public: 4046963143862
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023
• Report Date (Section F): 08/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2024
• Device Model Number: SW996K
• Device Catalogue Number: SW996K
• Device Lot Number: 52551471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2023
• Device Age: 49 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Date Report Sent to FDA: 08/10/2022