MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE; METHYL METHACRYLATE FOR CRANIPLASTY

Model Number	615.10.01S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hearing Impairment (1881); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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: part number: 615.10.01s, cranio's reinforced fast set putty 10cc ¿ sterile.Lot number: dsd8462 (sterile).Manufacturing location: (b)(4) / inspected and released by: (b)(4).Release to warehouse date: 30-dec-2016.Expiration date: 28-jul-2018.Lot quantity: 126.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 28-dec-2016 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and gama is specified at 25 min.- 32 max.The max results are documented at 31.9 and 32.2.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.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 on an unknown date, the patient underwent an acoustic neuroma resection retrosigmoid procedure.The patient was implanted with the titanium matrixneuro adaptation plate and putty cement.There was a surgical time of 559 minutes.There were no intra-operative complications.The patient is doing great after gross total resection of a massive vestibular schwannoma and a scar in the iac.The patient reports low back pain and issues with sleeping recently.Patient has no hearing on the right side.This is report 1 of 3 for (b)(4).

• Brand Name: CRANIOS REINFORCED FAST SET PUTTY 10CC-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: 10420109
• Report Number: 2939274-2020-03588
• Device Sequence Number: 3065910
• Product Code: GXP
• UDI-Device Identifier: 10887587058658
• UDI-Public: (01)10887587058658
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 07/28/2018
• Device Model Number: 615.10.01S
• Device Catalogue Number: 615.10.01S
• Device Lot Number: DSD8462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRIXNEURO ADAPT-PL 20HO T0.4 TI; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR