MAUDE Adverse Event Report: AESCULAP AG LYOPLANT 4X5CM; DURA SUBSTITUTE

Model Number	1066064
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility report # (b)(4).Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
It was reported to aesculap (b)(4) that a lyoplant 4x5cm was used during a craniectomy with a closure of the dura procedure performed on (b)(6) 2020.The lyoplant dural graft was sutured in place with 5-0 prolene sutures.During a followup surgical procedure performed on (b)(6) 2020, the lyoplant dural graft was found to have "disappeared." according to user facility report (b)(4) the patient returned to surgery thirteen (13) days later to repair a cerebrospinal fluid (csf) leak.During the surgery, the surgeon observed that the dural graft was missing.The cause of the graft failure was indicated as being unknown.The device was not available to be returned to the manufacturer for evaluation.A revision surgery was necessary.There were no signs of infection at the surgical site.
Event or Problem Description
Additional information was received: the current patient status is stable postoperatively, and it was confirmed that the only intervention required was the readmission for csf leak; and surgery occurred to repair and patch (with patients own tissue).Suturing of the original lyoplant dural graft was performed with 5-0 prolene suture.The operative report and medical records are not available at this time and there were no pictures nor x-rays taken.
Additional Manufacturer Narrative
Manufacturing evaluation: to date there is no device available for investigation.Therefore a investigation of the device itself was not possible.Due to the lack of information surrounding the reported case and without the complaint sample being available for investigation, a definite root cause cannot be determined.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.There are no similar complaints against the same lot number with this error pattern.In the event that the complaint sample will be provided to us for investigation in the future, an update of this report will be provided unsolicited.

• Brand Name: LYOPLANT 4X5CM
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10682974
• Report Number: 2916714-2020-00597
• Device Sequence Number: 19571954
• Product Code: GXQ
• UDI-Device Identifier: 04038653700974
• UDI-Public: 4038653700974
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K970851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 10/29/2020

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: 02/28/2025
• Device Model Number: 1066064
• Device Catalogue Number: 1066064
• Device Lot Number: 220125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90
• Date Report Sent to FDA: 10/29/2020