MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA; BONE PLATE

Model Number	421.528
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a debridement of surgical site with removal of retained hardware and bone and open reduction internal fixation (orif) of cranium due to infection.One (1) titanium low profile neuro strut plate, three (3) titanium low profile neuro burr hole cover, and sixteen (16) titanium low profile neuro screw self-drilling was removed due to local infection at the site.Patient initially injured self in a motor vehicular accident (mva) and was ejected from the car.Patient had multiple surgeries to multiple areas including her head and multiple debridements from the initial surgery on (b)(6) 2018.There was no surgical delay.Procedure outcome was successful.Patient is still in coma.This complaint involves twenty (20) devices.Please see the linked complaint (b)(4) which captures the additional 10 devices.This complaint is for one (1) ti low profile neuro burr hole cover 24mm dia.This report is 1 of 10 for (b)(4).
Additional 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: 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 was used for treatment, not diagnosis.

• Brand Name: TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8182085
• Report Number: 2939274-2018-55490
• Device Sequence Number: 1695758
• Product Code: JEY
• UDI-Device Identifier: 10887587050607
• UDI-Public: (01)10887587050607
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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 Model Number: 421.528
• Device Catalogue Number: 421.528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Weight: 68