MAUDE Adverse Event Report: AESCULAP AG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; CRANIAL IMPLANTS

Model Number	FF016
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with ff016-6 craniofix absorbabl.Clamp sterile 11mm.According to the complaint description, the patient underwent surgery in (b)(6) 2020 and was re-fixed with cfa in (b)(6) of the same year.A revision surgery was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4) patient info: (b)(6) girl.
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: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Manufacturing specifications were valid at the time of production.Explanation and rationale/conclusion and root cause: 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 investigtaion in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
• Common Device Name: CRANIAL IMPLANTS
• 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: 13043615
• Report Number: 9610612-2021-00776
• Device Sequence Number: 1750833
• Product Code: GXR
• UDI-Device Identifier: 04038653347971
• UDI-Public: 4038653347971
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: FF016
• Device Catalogue Number: FF016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 MO
• Patient Sex: Female