MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.540 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number	SD800.540
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
Device was used for treatment, not diagnosis.Patient weight not available for reporting.Unknown when infection began.Implants removed on an unknown date.Complainant part is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: (b)(4): dhr review, part number: sd800.540, lot number: h539444, manufacturing site: (b)(4), release to warehouse date: 03-jan-2018, supplier dhr review: n/a, no ncrs were generated during production.Record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 was implanted with a patient specific implant, matrixneuro plates and matrixneuro screws on (b)(6) 2018 for a cranioplasty.Patient developed infection and the implants were removed on an unknown date.Patient will be implanted with another patient specific implant.The surgery date has not been scheduled.This complaint involves an unknown number of devices (patient specific implant, matrixneuro plates and matrixneuro screws).This report is for 10 devices.This report is 1 of 10 for (b)(4).
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Date in initial report was (b)(6) 2018.Correct date should have been (b)(6) 2018.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 was implanted with a patient specific implant (psi) polyether ether ketone (peek) implant, four (4) matrixneuro x-plates, two (2) matrixneuro straight plates, and twenty (20) matrixneuro screws on (b)(6) 2018 for a cranioplasty.On unknown date, patient developed infection.Patient was returned to surgery on unknown date where the implants were removed.There was no surgical delay.The type of infection is unknown.Patient was not revised to additional hardware at that time.Patient was later revised to another psi implant on (b)(6) 2018.This report involves a total of 27 devices captured on three (3) report files: (b)(4).This report is for one (1) psi peek implant.This report is 1 of 10 for (b)(4).

• Brand Name: PSI SD800.540 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: 7310180
• Report Number: 2939274-2018-50825
• Device Sequence Number: 11075147
• Product Code: GXN
• UDI-Device Identifier: 10887587065991
• UDI-Public: (01)10887587065991(10)H539444
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: SD800.540
• Device Catalogue Number: SD800.540
• Device Lot Number: H539444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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: 16 YR