MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED NONALTERABLE

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, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, information was received from the surgeon that the peek implant had to be removed due to infection.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This complaint involves three (3) devices.This is 1 of 3 for report (b)(4).
Event or Problem Description
On (b)(6) 2019: update: it was reported that there wasn't any planning and the peek psi is a synthes implant.Therefore materialise could not have had any impact on this infection.The original materialise number was mu18-sun-zet.The final implant was given to kls due to custom titanium implant that was not available.In addition, in addition, the patient had already had the implant removed in a hospital (hospital staff didn¿t know the name of the facility) in alaska and are not able to obtain and send the implant back for inspection.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A review of the device history record.Device history lot part number sd800.440 lot number: h768032 date of manufacture: 10-26-2018 place of manufacture: brandywine plant.Part expiration date: n/a (non-sterile) device history batch null, device history review the device history record(s) showed that there were no non-conformances or issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: investigation summary product was not returned.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 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 SD800.440 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: 9199218
• Report Number: 2939274-2019-61546
• Device Sequence Number: 2639546
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD800.440
• Device Catalogue Number: SD800.440
• Device Lot Number: H768032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention