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

Model Number	421.528
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 or Problem Description
It was reported that on an unknown date, the patient underwent a microvascular decompression (mvd) procedure due to trigeminal neuralgia.The patient was implanted with titanium low profile neuro burr hole cover and mesh plates.There was a surgical time of 108 minutes.There were no intra-operative complications.The duration of follow up was of 787 days.The healing status/radiographic outcomes at final follow-up was that the patient had 70% improvement in pain after mvd, but continues to suffer.Recently the patient developed sharp, shooting recurrent pain.There were no post-operatives complication presented.The patient did not undergo reoperation.The other patient reported outcomes were that there was a dramatic improvement of throat pain and ear pain, has no hearing difficulty, and able to eat more because of pain free.No further information is available.Concomitant devices reported: plates: cmf (part number unknown, lot unknown, quantity 2).This report involves one (1) ti low profile neuro burr hole cover 24mm dia.This is report 1 of 3 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.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.
Event or Problem Description
Updated event description: this complaint involves an unknown number of devices.

• Brand Name: TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10407948
• Report Number: 2939274-2020-03535
• Device Sequence Number: 19471148
• Product Code: JEY
• UDI-Device Identifier: 10887587050607
• UDI-Public: (01)10887587050607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 08/10/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: CMF; UNK - PLATES: CMF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR