MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.440 PEEK IMPLANT; TREPHINE

Model Number	SD800.440
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
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.(b)(4).A review of the device history record: device history lot: part number: sd800.440, lot number: h837672, supplier lot number: n/a.Manufacture date or release to warehouse date: 02/13/2019.Expiration date: n/a.Supplier/manufacture site: (b)(4).No ncrs were generated during production of lot number h837672.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Raw material part number: 42031, raw material lot number: 7169629.Raw material heat number: 4511681136.Raw material supplier lot number: 4511681136.Manufacture date or release to warehouse date: 01/09/2013.Expiration date: n/a.Supplier/manufacture site: (b)(4).No ncrs were generated during production of raw material lot number 7169629.Review of the device history record showed that there were no issues during the manufacture of the raw material that would contribute to this complaint condition.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of the product or the raw material that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 or Problem Description
It was reported that on an unknown date, the polyetheretherketone (peek) implant had to be removed due to infection.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This complaint involves an unknown number of devices.This report is 1 of 3 for (b)(4).

• Brand Name: PSI SD800.440 PEEK IMPLANT
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8769721
• Report Number: 2939274-2019-59055
• Device Sequence Number: 16779132
• Product Code: HWK
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/10/2019

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: SD800.440
• Device Catalogue Number: SD800.440
• Device Lot Number: H837672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention