MAUDE Adverse Event Report: AESCULAP AG LYOPLANT ONLAY 10.0X12.5CM; CRANIAL IMPLANTS

Model Number 1067050

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was an issue with the product 1067050 - lyoplant onlay 10.0x12.5cm.According to the complaint description, the product caused a leakage of an unknown, clear liquid.It was located on the top side of the skull, around the parietal bone area, 1-2 months postoperatively, while putting skull flap back.They ensured the overlap of 1 centimeter for the case; and proceeded with correct side with onlay application not underlay.A revision surgery was not necessary, the physician monitored the patient's status.No infections occured.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

• Brand Name: LYOPLANT ONLAY 10.0X12.5CM
• Type of Device: 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: 18221305
• MDR Text Key: 329163770
• Report Number: 9610612-2023-00249
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1067050
• Device Catalogue Number: 1067050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1