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

Model Number 615.05.01S

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

Patient Problems Inflammation (1932); Pain (1994); Post Traumatic Wound Infection (2447)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: manufacturing location: dsm biomedical ¿ (b)(4).Release to warehouse date: 15-sep-2017.Expiration date: 28-mar-2019.Part number: 615.05.01s, cranios reinforced fast set putty 5cc ¿ sterile.Lot number: dse5440 (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 dsm dated 08-sep-2017 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and were within limits per nr.Based on this, the lot was determined to meet requirements and the disposition of the nr was ¿use as is¿.This lot met all 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.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 Description

It was reported that on (b)(6) 2017, the surgeon used two (2) cranios fast set putties for left retrosigmoid craniotomy.On (b)(6) 2018 the patient had a ct scan of the head that was unremarkable.The patient presented on an unknown date with post-op infection, inflammation, headache and pain.On (b)(6) 2018 the patient underwent incision with drainage and implants were removed.The washed-out material has been reported to look like spackle, and the surgical team has not retained material to ship back for investigation.The surgeon noted that it was not known if the cranios was solely responsible for the infection.Apparently surgeon had five (5) such cases where he had to wash out the patients.This complaint captures 1st case, other 4 cases are captured under related (b)(4).This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 2 of 2 for (b)(4).

• Brand Name: CRANIOS REINFORCED FAST SET PUTTY 5CC-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
• 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: 11323320
• MDR Text Key: 231681430
• Report Number: 2939274-2021-00843
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 10887587058641
• UDI-Public: (01)10887587058641
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

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: 03/28/2019
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSE5440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR