MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO BURR HOLE COVER 17MM DIA; BONE PLATE

Model Number	421.527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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.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 procedure due to trigeminal neuralgia.The patient was implanted with burr hole cover and an unknown mesh plates.There was a surgical time of 135 minutes.There were no intra-operative complications.The duration of follow up was of 1751 days.The healing status/ radiographic outcomes at final follow-up was that the patient reports delayed facial numbness after gamma knife and reported 100% improvement.The patient was pleased with results of gamma knife but her pain recurred two weeks ago, but she feels this is associated with nasal drainage.Left medial sphenoid encephalocele - stable after middle fossa craniotomy.The patient underwent reoperation because of the left frontal/temporal craniotomy for repair of meningoencephalocele and gamma knife radiosurgery for right-sided trigeminal neuralgia.The procedure and patient outcome were unknown.This is report 1 of 3 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO BURR HOLE COVER 17MM 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: 10424703
• Report Number: 2939274-2020-03615
• Device Sequence Number: 3105106
• Product Code: JEY
• UDI-Device Identifier: 10887587050591
• UDI-Public: (01)10887587050591
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: 421.527
• Device Catalogue Number: 421.527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: CMF; UNK - SCREWS: CMF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR