MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.426 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number	SD800.426
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Date of postoperative infection development is unknown.Implanted in (b)(6) 2017; exact date is unknown.Explanted in (b)(6) 2018, exact date is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent removal of a peek psi implant (craniotomy) on an unknown date in (b)(6) due to an infection.The patient underwent an initial craniotomy procedure in (b)(6) 2017 to be implanted with the synthes peek psi implant as a bone flap along with an unknown quantity of unknown screws (manufactured by a competitor) to fixate the implant.Subsequently, the patient developed an infection in the vicinity of the implants and hence underwent the removal of all implanted devices.The removal surgery was completed successfully and without any complications.The status of the patient, suffering from cancer, was unknown at the end of the removal procedure.The facility plans to re sterilize the peek psi implant and reuse in this patient.This report is for one (1) psi sd800.426 peek implant.This is report 1 of 1 for complaint (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.Dhr review was completed.Brandywine dhr reivew , product code: sd800.426 , lot number: h468655 , manufacturing site:(b)(4), supplier dhr: n/a , release to warehouse date: 02-oct-2017 , no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 SD800.426 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: 7434475
• Report Number: 2939274-2018-51736
• Device Sequence Number: 10791238
• Product Code: GXN
• UDI-Device Identifier: 10887587064505
• UDI-Public: (01)10887587064505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: SD800.426
• Device Catalogue Number: SD800.426
• Device Lot Number: H468655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR