MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO ADAPTION PLATE 20 HOLES; BONE PLATE

Model Number	04.503.072
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.(b)(4).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.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 patient underwent an acoustic neuroma resection retrosigmoid procedure.The patient was implanted with titanium matrixneuro adaptation plate and cranios reinforced fast set putty.There was a surgical time of 568 minutes.There were no intra-operative complications.Postoperatively, on an unknown date, patient was admitted to hospital for wound drainage, stopped with glue.It was unclear whether postoperative complication(s) was (were) due to device.The infected bone plate treated with surgery to remove all hardware.The healing status/radiographic outcomes at final follow-up was the large symptomatic left acoustic neuroma doing great after near total resection of schwannoma.Infection has been treated, and his wound looks good.He has no bone flap because it was removed for infection.Other outcome assessments or patient reported outcomes was the left eye tearing at times while eating.Ongoing neck spasms and soreness.No further information is available.This report is for a ti matrixneuro adaption plate 20 holes.This is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXNEURO ADAPTION PLATE 20 HOLES
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10425903
• Report Number: 2939274-2020-03635
• Device Sequence Number: 16920317
• Product Code: JEY
• UDI-Device Identifier: 10887587018041
• UDI-Public: (01)10887587018041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 04.503.072
• Device Catalogue Number: 04.503.072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; UNK - SCREWS: MATRIXNEURO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR