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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Part: 615.10.01s, synthes lot: dse0562, supplier lot: dse0562, release to warehouse date: march 08, 2017, expiration date: august 28, 2018, supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.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.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.(b)(4).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.Patient was implanted with an unknown plate and putty cement.The patient had medium size s/p resection of cp angle component complicated by inability to open iac because of severe cerebellar swelling, requiring decompressive cerebellar craniectomy two days later and was resolved.Patient outcome is unknown.This report is for a cranio's reinforced fast set putty 10cc-sterile.This is report 1 of 3 for (b)(4).

• Brand Name: CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10421202
• MDR Text Key: 203366024
• Report Number: 2939274-2020-03605
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 10887587058658
• UDI-Public: (01)10887587058658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 615.10.01S
• Device Catalogue Number: 615.10.01S
• Device Lot Number: DSE0562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR