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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUP CLAV PL LAT EXTN/7H/LT/120 PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUP CLAV PL LAT EXTN/7H/LT/120 PLATE, FIXATION, BONE Back to Search Results
Model Number 02.112.093
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative

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. 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, the patient underwent a fracture fixation for a shaft fracture utilizing lcp superior clavicle plate. Dbm 5cc was used as an additional surgical intervention. A reoperation was done due to hardware removal, patient could feel implant. Union was achieved after 8 weeks. No post-operative complications reported. Concomitant devices reported: unk, screws: (part# unknown; lot# unknown; quantity: 4). This report is for (1) 3. 5 lcp sup clav pl lat extn/7h/lt/120. This is report 1 of 5 for complaint (b)(4).

 
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Brand Name3.5 LCP SUP CLAV PL LAT EXTN/7H/LT/120
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12388118
MDR Text Key268888090
Report Number2939274-2021-05009
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial
Report Date 08/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.112.093
Device Catalogue Number02.112.093
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 Received08/24/2021
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: 08/30/2021 Patient Sequence Number: 1
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