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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(6). 510k: this report is for 3 unknown 3. 5mm cortex screws/unknown lot. Part and lot number are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient underwent removal of screws and reapplication of external fixator on (b)(6) 2018 due to infection, non-union, and screws backing out. The patient had an external fixator and three (3) 3. 5mm cortex screws implanted to stabilize the tibia fracture on (b)(6) 2018. The external fixator was removed on (b)(6) 2018. The patient was put in a splint at that time. The patient returned to surgery on (b)(6) 2018 for removal of screws and reapplication of an external fixator as patient walked on leg and screws are backing out. The patient also has an infection and non-union. The surgery was successfully completed with no delay. The patient outcome was reported as okay. This report is for three (3) unknown 3. 5mm cortex screws. This is report 1 of 1 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7484772
Report Number2939274-2018-51999
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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