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 Problem Inadequate Osseointegration (2646)

Event Date 03/11/2022

Event Type  Injury  

Event Description

On or about unknown date, patient reported that his medical device was hooked up to computer system for entertainment purposes and to harass and abuse him, and it also has led to physical changes in my body like shortening of my legs and changes in my facial features, and already reported to the fbi.Patient stated "i think these people are using biotechnology on me without consent." there is no further information.This report is for one (1)unk - screws: trauma.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown screw trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is the patient.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.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15123115
• MDR Text Key: 296794444
• Report Number: 2939274-2022-02995
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/28/2022
• 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