MAUDE Adverse Event Report: AESCULAP AG LYOPLANT ONLAY 5.0X5.0CM; DURA REPLACEMENT

Model Number 1067020

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 10/30/2019

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 a lyoplant onlay, per information from medwatch 5092415.It was reported that the patient had a lyoplant graft for chiari decompression with subsequent subdural hygromas and aseptic meningitis.It is reported this was a serious injury that had the outcome of hospitalization.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient and reporter information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: no product available for investigation.Investigation of the product will be updated after receipt of the product, if applicable.Batch history record: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Rationale: no causality between the product and the mentioned issue can be found.An infection of the patient that already existed before the surgery cannot be excluded.Contraindications and warnings can be found in the ifu.A capa is not necessary.

• Brand Name: LYOPLANT ONLAY 5.0X5.0CM
• Type of Device: DURA REPLACEMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9781808
• MDR Text Key: 182304473
• Report Number: 9610612-2020-00029
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K122791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1067020
• Device Catalogue Number: 1067020
• Device Lot Number: 219075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other