MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE; METHYL METHACRYLATE FOR CRANIOPLASTY

Model Number	615.03.01S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Facial Nerve Paralysis (1846)
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.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.Patient was implanted with unknown bone plates and putty cement.Immediately after the surgery, the patient experienced severe facial paralysis.The patient had right masseter nerve to facial nerve transfer, and temporalis tendon transfer.The complication was resolved.The patient outcome is unknown.No further information is available.This report is for one (1) cranios reinforced fast set putty 3cc-sterile.This is report 1 of 3 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 #: 615.03.01s , synthes lot number: dsc7714, supplier lot #: dsc7714, release to warehouse date: july 15, 2015, supplier: (b)(4).Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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 3CC-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: 10391577
• Report Number: 2939274-2020-03464
• Device Sequence Number: 11231499
• Product Code: GXP
• UDI-Device Identifier: 10887587058634
• UDI-Public: (01)10887587058634
• 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: health professional,study
• 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 Model Number: 615.03.01S
• Device Catalogue Number: 615.03.01S
• Device Lot Number: DSC7714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIXMIDFACE ADAPT PLT/20 HOLE/0.8MM; UNK - SCREWS: MATRIXMIDFACE; TI MATRIXMIDFACE ADAPT PLT/20 HOLE/0.8MM; UNK - SCREWS: MATRIXMIDFACE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR