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

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, quantity# 1).Ti low profile neuro adaption plate 20 holes (part#: 421.520, lot#: unknown, quantity# 1).This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 4 of 4 for (b)(4).

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: manufacturing location: dsm biomedical ¿ kensey nash / inspected and released by: monument, release to warehouse date: march 30, 2015, expiration date: aug 28, 2018, part number: 615.05.01s, cranios reinforced fast set putty 5cc ¿ sterile, lot number: dsc6246 (sterile).Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance supplied by dsm dated march 25, 2015 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and determined to be confirming.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review: aug 17, 2020: dhr reviewed by: mschoenfeld.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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
• Type of Device: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10407872
• MDR Text Key: 203091446
• Report Number: 2939274-2020-03532
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 10887587058641
• UDI-Public: (01)10887587058641
• Combination Product (y/n): N
• PMA/PMN Number: K102018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• 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 Expiration Date: 08/28/2018
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSC6246
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1
• Treatment: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES; UNK - SCREWS: CMF
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR