MAUDE Adverse Event Report: AESCULAP AG LYOPLANT ONLAY 7.5X7.5CM; DURA REPLACEMENT

Model Number 1067040

Device Problem Degraded (1153)

Patient Problems Cerebrospinal Fluid Leakage (1772); Failure of Implant (1924)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was an issue with 1067040 - lyoplant onlay 7.5x7.5cm.According to the complaint description, the surgeon placed lyoplant onlay on a patient, and the patient developed a pseudomeningocele and chemical meningitis.He took the patient back to the operation room, 3 1/2 months after initial implantation, thinking maybe a suture had come lose.However, the sutures were all in place and there was a dehiscence of the lyplant onlay and cerebrospinal fluid (csf) was leaking out".A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

No changes required.

• Brand Name: LYOPLANT ONLAY 7.5X7.5CM
• Type of Device: DURA REPLACEMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11700475
• MDR Text Key: 246483811
• Report Number: 2916714-2021-00059
• Device Sequence Number: 1
• Product Code: GXQ
• UDI-Device Identifier: 04046963958701
• UDI-Public: 4046963958701
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2021,03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1067040
• Device Catalogue Number: 1067040
• Device Lot Number: 219491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2021
• Distributor Facility Aware Date: 03/26/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female