MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM; CRANIAL IMPLANTS

Model Number FM921T

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

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 cranioplate.It was reported that during surgery to fix the skull with b.Braun titanium plate and screw system, the 'placte' was damaged and the screw was fractured.No injury resulted from the event.Replaced with new plate and screw immediately and the surgery was finished successfully.Surgery was not delayed.An additional medical intervention was not necessary.The malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00868 ((b)(4) fm981t).

• Brand Name: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9527546
• MDR Text Key: 179424324
• Report Number: 9610612-2019-00866
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Device Lot Number: 52494632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2019
• 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
• Patient Age: 55 YR