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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient date of birth/age, sex and weight were not provided for reporting. Date of event is unknown. This report is for one (1) unknown tibial nail. Part#, lot# and udi # is not available. Device was not explanted at the time of reporting. Device remained implanted. Device is not expected to be returned for manufacturer review/investigation. Reporter contact number was not provided for reporting. This report is for one (1) unknown tibial nail. Pma/510(k) number is not available. (b)(4) used to capture patient will required additional medical/surgical intervention. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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 a patient underwent a left tibia nail procedure on the left leg on (b)(6) 2016. The area is fully healed. However, the patient is experiencing pain and swelling. Patient has not been revised to date as the area is very swollen. Surgeon and allergist are determining the next appropriate course of action. This report is for one (1) unknown tibial nail. This is report 1 of 2 for (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key7122698
MDR Text Key95018027
Report Number2939274-2017-50321
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/16/2017
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

Patient Treatment Data
Date Received: 12/15/2017 Patient Sequence Number: 1
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