MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 6MM HXC-STERILE; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Model Number 311.061.01S

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); 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) 2017, the patient underwent a removal surgery of a rapid resorb mesh plates and seven (7) cortex screws due to allergic reaction that caused inflammation and skin breakdown.The skin breakdown caused an open wound that had to be cleaned regularly.The plate was exposed under surgical incision site.The date of the original surgery was on (b)(6) 2016.The procedure was completed successfully.The patient had a small scar in the temporal area where the incisions and skin breakdown happened.This is report 8 of 8 for (b)(4).

Event Description

Updated: it was reported that on (b)(6) 2017, the patient underwent a second surgery was performed due to allergic reaction to the material under the surgical site that caused inflammation and skin breakdown.Items were not removed out of patients head because they are resorbable and dissolve.Patient open wound had to be cleaned and cared for and required more visits to the surgeon for wound healing.

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.Devices were not removed; they reabsorb.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: TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 6MM HXC-STERILE
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8754394
• MDR Text Key: 149829593
• Report Number: 2939274-2019-58972
• Device Sequence Number: 1
• Product Code: HBG
• UDI-Device Identifier: 10887587035857
• UDI-Public: (01)10887587035857
• Combination Product (y/n): N
• PMA/PMN Number: K153587
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 311.061.01S
• Device Catalogue Number: 311.061.01S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention