MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE; METHYL METHACRYLATE FOR CRANIOPLASTY

Model Number 615.05.01S

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Post Operative Wound Infection (2446); 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 an unknown date, the surgeon had to wash out infections that have used cranios fast set putty.Procedure and patient outcome were unknown.Apparently surgeon had 5 such cases where he had to wash out the patients.This complaint captures 5th case, other 4 cases are captured under related complaints (b)(4).This report is for one 1 cranios reinforced fast set putty 5cc-sterile.This is report 1 of 1 for complaint (b)(4).

Event Description

It was noted the procedure was a bicoronal craniotomy.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated event description.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.B5: corrected device name to cranios reinforced fast set putty 10cc-sterile and number of devices involved.

Event Description

Updated event description: it was reported that on (b)(6) 2020, the patient underwent removal of the two (2) cranios fast set putty 10cc to wash out infections since the incision had drainage.Originally, the patient underwent a bicoronal craniotomy on (b)(6) 2019.A head ct scan was taken on (b)(6) 2020.The surgeon took the patient back to the operating room and washed/debrided out the infection.Procedure and patient outcome were unknown.Apparently surgeon had five (5) such cases where he had to wash out the patients.This complaint captures 5th case, other 4 cases are captured under related complaints (b)(4), (b)(4), (b)(4), and (b)(4).This report is for one (1) cranios reinforced fast set putty 10cc-sterile.This is report 1 of 2 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.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 history lot part # 615.0010.01s, synthes lot # dse0562, supplier lot # dse0562, release to warehouse date: mar 08, 2017 , supplier: (b)(4), no ncr's were generated during production.Device history review : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 CRANIOPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10844189
• MDR Text Key: 216384969
• Report Number: 2939274-2020-05168
• 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,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 615.05.01S
• Device Catalogue Number: 615.10.01S
• Device Lot Number: DSE0562
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR