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

Model Number 421.520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Pain (1994); Visual Impairment (2138)

Event Type  Injury  

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 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
• Type of Device: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10407860
• MDR Text Key: 203109654
• Report Number: 2939274-2020-03530
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587050539
• UDI-Public: (01)10887587050539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421.520
• Device Catalogue Number: 421.520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR