MAUDE Adverse Event Report: SYNTHES GMBH PSI 140*100*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.435

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: product code: sd800.435; lot #: 282p640; manufacturing site: (b)(4).Release to warehouse date: 13 jul 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the patient specific implant (psi) did not match the patient's bone shape.There was a surgical delay of ten (10) minutes.The procedure was successfully completed using titanium mesh.There was no patient consequence.This report is for one (1) psi 140 100 40 peek.This is report 1 of 1 for (b)(4).

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12704582
• MDR Text Key: 284884011
• Report Number: 8030965-2021-09050
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341357
• UDI-Public: (01)07611819341357
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.435
• Device Lot Number: 282P640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Patient Sequence Number: 1