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 Break (1069)

Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).A device history record (dhr) review was conducted: manufacturing location: supplier: (b)(4) / inspected and released by: (b)(4), release to warehouse date: 16-may-2016, expiration date: 28-aug-2017, part number: 615.10.01s, cranios reinforced fast set putty 10cc¿ sterile, lot number: dsd3815 (sterile), lot quantity: (b)(4), sterility requirements on certificate were reviewed and determined to be conforming.This lot met all dimensional, 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.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.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) 2018, the patient underwent removal of bone cement due to cement fragmentation and infection that was known on (b)(6) 2017.Findings at last follow-up temporal retrusion right, left posterior skull bony contour irregularities.The patient participates in martial arts and notes repeated trauma to the head and, over the past several months, had noted some boggy inflammation in the right forehead region without frank infection.More recently, it developed a small abscess on the upper lid on the right, suggesting some sort of infection of the alloplast, which had presumed to be traumatically fragmented, had chronic inflammation and fragmentation of the phosphate cement both on the right and left temporal regions.It appears that the patient had this with an infection through the right upper lid.The original implant date was on (b)(6) 2016.It is unknown if there was a surgical delay.The procedure and patient outcomes were unknown.This report is for one (1) cranios reinforced fast set putty 10cc-sterile.This is report 2 of 2 for complaint (b)(4).

Event Description

Modified event description: it was reported that on (b)(6) 2018, the patient underwent removal of bone cement due to cement fragmentation and infection that was known on (b)(6) 2017.The patient had cephalexin antibiotic therapy for a period of time.Findings at last follow-up temporal retrusion right, left posterior skull bony contour irregularities.Reoperative findings the patient participates in martial arts and notes repeated trauma to the head and, over the past several months, had noted some boggy inflammation in the right forehead region without frank infection.More recently, it developed a small abscess on the upper lid on the right, suggesting some sort of infection of the elastoplast, which had presumed to be traumatically fragmented, had chronic inflammation and fragmentation of the phosphate cement both on the right and left temporal regions.It appears that the patient had this with an infection through the right upper lid.The original implant date was on (b)(6) 2016.It is unknown if there was a surgical delay.The procedure and patient outcomes were unknown.

Manufacturer Narrative

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.H10 additional narrative: b5: modified event description.G4: 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 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
• MDR Report Key: 9587274
• MDR Text Key: 189186221
• Report Number: 2939274-2020-00176
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 10887587058658
• UDI-Public: (01)10887587058658
• 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: 12/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 615.10.01S
• Device Catalogue Number: 615.10.01S
• Device Lot Number: DSD3815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR