MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES; PLATE, BONE

Model Number	421.520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Neurological Deficit/Dysfunction (1982); Pain (1994); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 due to acoustic neuroma.The patient was implanted with unknown bone plates and cranios reinforced fast sst putty.The procedure was successfully completed.There were no post-operative complications.Other outcome assessments or patient-reported outcomes were decreased peripheral vision on the right, headaches, decreased appetite, first bite syndrome, gait unsteady, dysphonia, contralateral vocal cord paralysis, diplopia on lateral gaze to the right (right vi parietal) in right lateral gaze, endgaze nystagmus, and amplitude skew deviation.He is experiencing oscillopsia in the right lateral gaze.Any further procedure or patient outcomes were not reported.Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity # 1), cranios reinforced fast set putty 5cc-sterile (part # 615.05.01s, lot # dsc3595/ dsc6246, quantity # 2).This report is for one (1) ti low profile neuro adaption plate 20 holes.This is report 2 of 4 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10407860
• Report Number: 2939274-2020-03530
• Device Sequence Number: 11401100
• Product Code: JEY
• UDI-Device Identifier: 10887587050539
• UDI-Public: (01)10887587050539
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• 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): 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: 421.520
• Device Catalogue Number: 421.520
• 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: 08/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR