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

Model Number	615.05.01S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hearing Impairment (1881); 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).A device history record (dhr) review was conducted: manufacturing location: (b)(4), inspected and released by: (b)(4), release to warehouse date: 15-mar-2017, expiration date: 28-sep-2018, part number: 615.05.01s, cranios reinforced fast set putty 5cc ¿ sterile, lot number: dse0579 (sterile), lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 09-mar-2017 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and it is unknown whether exceeding specified maximum may have contributed to the reported complaint condition.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.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 a microvascular decompression procedure.Patient was implanted with putty cement norian 5cc.Postoperatively, when the surgeon went to cut it, the patient's hearing decreased to 1m second delay on the baers.Therefore, he cut only part of the nervus intermedius.The surgeon decided not to pursue it any further as the patient has no hearing on the contralateral ear and the postoperative complication was resolved.Patient outcome is unknown.No further information is available.This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 CRANIPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10426415
• Report Number: 2939274-2020-03652
• Device Sequence Number: 3859912
• Product Code: GXP
• UDI-Device Identifier: 10887587058641
• UDI-Public: (01)10887587058641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 09/28/2018
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSE0579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR