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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 10H/LT 230MM LONG PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 10H/LT 230MM LONG PLATE, FIXATION, BONE Back to Search Results
Model Number 02.104.030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pocket Erosion (2013)
Event Type  Injury  
Manufacturer Narrative
Patient weight is unknown. Date of event: unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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 implantation of two (2) locking compression plate (lcp) distal humeral plates and unknown screws on (b)(6) 2018. On an unknown date, patient developed hardware issues. On (b)(6) 2018, patient underwent hardware removal due to the plates breaking through the skin. There was no surgical delay reported. Procedure was completed successfully and patient status was stable. This is report 1 of 3 for (b)(4).
 
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Brand Name3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 10H/LT 230MM LONG
Type of DevicePLATE, FIXATION, BONE
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7681391
MDR Text Key113767628
Report Number2939274-2018-52844
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number02.104.030
Device Catalogue Number02.104.030
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 Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
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