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

Model Number SD800.444

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 282063879
• Report Number: 2939274-2021-07037
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065151
• UDI-Public: (01)10887587065151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: CMF; UNK - SCREWS: CMF
• Patient Outcome(s): Required Intervention