MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.442 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.442

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reports an event in (b)(6) as follows: it was reported that a patient specific implants had to be explanted because of a wound healing disorder.Patient will receive a new implant.No other information provided.This report is for one (1) psi peek implant.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

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

Further it was reported that the initial implant date was (b)(6) 2019.The patient underwent hardware removal surgery on (b)(6) 2019 because of previous multiple surgeries (not psi implantation), complex wound healing situation, severely scarred tissue, wound healing disorder with galea abscess, (increasing infection values).It was also reported that hardware was explanted on (b)(6) 2019, however new psi implant was implanted and cranial defect was closed successfully on (b)(6) 2019.There were no issues during revision surgery.

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.Device history lot: part: sd800.442, lot: 4l33068, manufacturing site: mezzovico, release to warehouse date: 16.April 2019.A manufacturing record evaluation was performed for the finished device 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.

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.H10 additional narrative updated data-h6.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 SD800.442 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: 8885381
• MDR Text Key: 154119281
• Report Number: 8030965-2019-67141
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341685
• UDI-Public: (01)07611819341685
• 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,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.442
• Device Lot Number: 4L33068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention