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

Model Number	FF016
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a 6 craniofix absorbabl.Clamp sterile 11mm (part # ff016) was used during a procedure performed on an unknown date.According to the complainant, three (3) months after the surgical procedure, the scalp just above the cfa contracted and became thin, and eventually the scalp was torn.The doctor re-sutured in the outpatient department, however, after approximately a half year, the patient was re-sutured with general anesthesia surgery.The complaint device has not been returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Correction: b5 updated - original implantation year.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.
Event or Problem Description
Original surgery: 2018, date unknown.

• 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: 12960559
• Report Number: 9610612-2021-00775
• Device Sequence Number: 14804946
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• 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: 12/08/2021
• 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: 10 YR
• Patient Sex: Female