MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.402 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; reportedly the incident occurred in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.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 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 (b)(4) reports an event as follows: it was reported on (b)(6) 2019, the patient underwent facial enlargement surgery of the anglomandibular part utilizing a patient specific implant - polyetheretherketone (peek).It was unknown if there was a surgical delay.After the surgical operation, the patient presented with swelling on the left side of the face affected by the prosthesis.The patient is on antibiotic therapy.Reportedly the patient is now healthy and the swelling is gone.This report is for a patient specific implant.This is report 1 of 1 for (b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, the patient underwent facial enlargement surgery of the anglomandibular part utilizing a patient-specific implant - polyetheretherketone (peek).After the surgical operation, the patient presented swelling on the left side of the face affected by the prosthesis.The patient is on antibiotic therapy.It is unknown if there was a surgical delay.Patient is stable.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: PSI SD800.402 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8366049
• MDR Text Key: 136995397
• Report Number: 8030965-2019-61348
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819337749
• UDI-Public: (01)07611819337749
• 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,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR