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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Wound Infection (2447)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 11323320
• Report Number: 2939274-2021-00843
• Device Sequence Number: 4139969
• Product Code: GXP
• UDI-Device Identifier: 10887587058641
• UDI-Public: (01)10887587058641
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR