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

Model Number 421.527

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

Patient Problems Pain (1994); Hypoesthesia (2352); 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 patient underwent a microvascular decompression procedure due to trigeminal neuralgia.Patient was implanted with an unknown mesh plates and burr hole cover.There was a surgical time of one-hundred thirty-five (135) minutes.There was no intra-operative complication.The healing status and radiographic outcome at the final follow-up was that the surgery helped for about one year, but pain has recurred.Three (3) weeks ago, the patient had a severe recurrence, and required medications, and had mild numbness of the face in the v2/v3 region at 80%.There was no post-operative complication presented.The patient did not undergo re-operation.The patient outcome is unknown.No further information is available.This report is for one (1) ti low profile neuro burr hole cover 24mm dia.This is report 1 of 3 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10427134
• MDR Text Key: 203635583
• Report Number: 2939274-2020-03665
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587050591
• UDI-Public: (01)10887587050591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421.527
• Device Catalogue Number: 421.528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR