MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.541 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number	SD800.541
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 or Problem Description
It was reported that on an unknown date, the patient developed soft tissue infection on scalp, so the surgeon had to remove the peek implant to treat the infection.At a later date when infection resides, a new peek implant will be made and implanted.Surgical delay and procedure outcome are unknown.Patient involvement was unknown.This complaint involves one (1) device.This report is for one (1) psi sd800.541 peek implant.This report is 1 of 3 for (b)(4).
Additional 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: h3, h6: complaint products was implanted and not available to return.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 SD800.541 PEEK IMPLANT
• Common Device Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10003265
• Report Number: 2939274-2020-02064
• Device Sequence Number: 11282110
• Product Code: GXN
• UDI-Device Identifier: 10887587066004
• UDI-Public: (01)10887587066004
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD800.541
• Device Catalogue Number: SD800.541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PSI SD800.541 PEEK IMPLANT; UNK - PLATES; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention