MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

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

This report is for an unknown screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 (mvd) procedure due to trigeminal neuralgia.The patient was implanted with burr hole cover and an unknown mesh plates.There was a surgical time of one-hundred forty-six (146) minutes.There were intra-operative complications.As the surgeon turned up towards the trigeminal nerve and then he encountered significant venous bleeding from a bridging vein proximal to the petrosal dandy vein.It was presumed that there must be a large petrosal vein bridging vein from the cerebellum to the petrosal sinus, but physician could not see it, and therefore it was packed that area with gelfoam.The surgeon had to wait several minutes for hemostasis and as the venous bleeding stopped, the procedure continued.The duration of follow up was of 1972 days.The healing status/radiographic outcomes at final follow-up was that the patient post procedure reported 100% relief to pain.It was also reported that patient had 50% numbness in the right tongue post mvd with sharp shooting pain in the right v2/v3 returned about nine (9) months ago.There were no post-operatives complication presented.The patient did not undergo reoperation.No further information is available.This report is for one (1) unk - screws: trauma.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10426935
• MDR Text Key: 203636897
• Report Number: 2939274-2020-03662
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• 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: 56 YR