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 Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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) 2019, the patient underwent removal of hardware due to infection that was known on (b)(6) 2016.The original date of the implant was on (b)(6) 2016.Bone and soft tissue were debrided and bone and hardware was removed in the left frontal bone.The patient has a sheet of titanium mesh over the cranial defect in the left frontal bone and has periodically had breakdown and healing and breakdown and healing over this area.It was felt that they needed to explore the wound, remove some of the hardware, wash it out, and close it in layers and try to determine if this would definitively solve the problem.This is report 1 of 4 for complaint (b)(4).

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.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

Updated event description: it was reported that on (b)(6) 2019, the patient underwent a hardware removal due to chronic infection.Originally, the patient had an implantation using a titanium mesh and screws due to cranial vault reshaping in infancy in (b)(6) 2016.However, complication was observed due to infection that was known in (b)(6) 2016 and that patient was on antibiotic therapy of cephalexin.Thus, a re-operation was done in (b)(6) 2016.Unfortunately, a re-operative finding shown that the cranioplasty material in some areas looked quite satisfactory but in other areas was obviously infected.It was also mentioned that this would need to be removed, and the surgeon aware that there was a subjacent frontal bone titanium mesh cranioplasty on the left that would need to be removed and replaced.So, wound culture was done with normal skin flora, no fungus was noted and wound culture in office grew pseudomonas and was on bactrim and cipro pre-op.Thus, another surgery was done on (b)(6) 2019 wherein bone and soft tissues were debrided, and bone and hardware were removed in the left frontal bone.The patient has a sheet of titanium mesh over the cranial defect in the left frontal bone and has periodically had breakdown and healing and breakdown and healing over this area.It was felt that they needed to explore the wound, remove some of the hardware, wash it out, and close it in layers and try to determine if this would definitively solve the problem.

• 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: 9587054
• MDR Text Key: 186617575
• Report Number: 2939274-2020-00170
• 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

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 615.10.01S
• Device Catalogue Number: 615.10.01S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR