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

Model Number 615.05.01S

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

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

It was reported that on (b)(6) 2020, the patient underwent removal of the implant to wash out infections that have used cranios fast set putty.Originally, the patient underwent left retrosigmoid craniotomy on (b)(6) 2018.Procedure and patient outcome were unknown.This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : manufacturing location: supplier - dsm biomedical - kensey nash / inspected and released by: monument, release to warehouse date: 27-oct-2017, expiration date: 28-jan-2019, part number: 615.03.01s, cranios reinforced fast set putty 3cc¿ sterile, lot number: dse7149 (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 received from dsm dated 18-oct-2017 was reviewed and determined to be conforming.Sterility requirements on certificate were reviewed and determined to be conforming.This lot met all dimensional, 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 history batch null, device history review 02-feb-2021: dhr reviewed, this lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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 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
• 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: 11324769
• MDR Text Key: 232170096
• Report Number: 2939274-2021-00854
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.03.01S
• Device Lot Number: DSE7149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR