MAUDE Adverse Event Report: AESCULAP AG NEURO-PATCH 6X8CM; DURA REPLACEMENT

Model Number	1064029
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receipt of this complaint this complaint was evaluated as not beeing a reportable incident.Evaluation was based on information of risk file.Patient harm was later updated from no patient hazard to additional medical intervention.Therefore, this case was reevaluated and decided that this case now needs submission due to a patient risk.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.However, a product-safety-case has been initiated to evaluate the information received as well as the video-file.Final results are pending.From the provided video it can be recognised that moisture passes through the implant after a certain time.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.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 x probability 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.An exact cause cannot be determined at this moment.Further investigations are on-going.Based upon the investigations results a capa is not necessary.
Event or Problem Description
It was reported to aesculap ag that a neuro-patch 6x8cm (part # 1064029) was used during a detethering the spinal cord and repair dura defect procedure performed on (b)(6) 2021.According to the complainant, leakage occurred after suture.The patch was not replaced, however, the physician used duragen and tissue gel to prevent further leakage.Reportedly, the wound has no exudation at present, the patient is recovering well.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: product was not provided.Therefore, no physical investigation possible.However, a product safety case (psc) has been initiated to evaluate the information received as well as the video-file.Outcome of psc: there is no potentially increased risk for the patient, user or third parties.Based on feedback from the customer, the patient is recovering well.The implantation of the product on the open spina bifida is already described as a contraindication in the instructions for use (ifu).Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: please see above.Conclusion and measures / preventive measures: due to the current deviation and according to the explanation above, the root cause of the problem is most probably usage-related.Corrective action: a psc had been requested.A capa will not be requested because there was no potentially increased risk and no systematic issue.

• Brand Name: NEURO-PATCH 6X8CM
• Common Device Name: DURA REPLACEMENT
• 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: 13509336
• Report Number: 9610612-2022-00008
• Device Sequence Number: 11772137
• Product Code: GXQ
• UDI-Device Identifier: 04038653700783
• UDI-Public: 4038653700783
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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 Expiration Date: 08/31/2025
• Device Model Number: 1064029
• Device Catalogue Number: 1064029
• Device Lot Number: 220371
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• 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: 7 MO
• Patient Sex: Female