MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; METHYL METHACRYLATE FOR CRANIOPLASTY

Model Number	615.05.01S
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
If the information is unknown, not available or does not apply, the section/field of the form is left blank.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# dsc6246, quantity# 1), ti low profile neuro adaption plate 20 holes (part# 421.520, lot# unknown, quantity# 1) this report is for 1 cranios reinforced fast set putty 5cc-sterile.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
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.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 history lot: part number: 615.05.01s, synthes lot number: dsc3595, supplier lot number: n/a, release to warehouse date: dec 29, 2014, expiration date: aug 28, 2016, supplier: dsm biomedical-kensey nash.No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE
• Common Device Name: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10407857
• Report Number: 2939274-2020-03529
• Device Sequence Number: 2552751
• Product Code: GXP
• UDI-Device Identifier: 10887587058641
• UDI-Public: (01)10887587058641
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102018
• 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): 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 Expiration Date: 08/28/2016
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSC3595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES; UNK - SCREWS: CMF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR