MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.444 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number	SD800.444
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
Event or Problem Description
It was reported that on an unknown date, the patient specific implant will be removed due to infection.The patient outcome was unknown.This complaint involves an unknown number of devices.This report is for (1) psi sd800.444 peek implant.This is report 1 of 3 or complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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: part number: sd800.444-us, lot number: 343p538, part manufacture date: 08-11-2021, manufacturing location: (b)(4), part expiration date: n/a , nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the patient specific implant (psi) was processed through the normal machining, laser etch, finishing, inspection, and packaging operations.The product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Device history review the product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.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 SD800.444 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
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12977326
• Report Number: 2939274-2021-07037
• Device Sequence Number: 17350899
• Product Code: GXN
• UDI-Device Identifier: 10887587065151
• UDI-Public: (01)10887587065151
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K033868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: SD800.444
• Device Catalogue Number: SD800.444
• Device Lot Number: 343P538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: CMF; UNK - SCREWS: CMF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown