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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP OLECRANON PL 6H/LT/142 PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP OLECRANON PL 6H/LT/142 PLATE, FIXATION, BONE Back to Search Results
Model Number 02.107.306
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: additional device product codes: hwc. 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 on an unknown date, a 2. 7mm/3. 5mm variable angle lcp olecranon plate broke and needed to be revised. The procedure and patient outcome were unknown. This report involves one (1) plate. This is report 1 of 1 for pc-(b)(4).
 
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Brand Name2.7/3.5 VA-LCP OLECRANON PL 6H/LT/142
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key13978672
MDR Text Key288680065
Report Number2939274-2022-01165
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.107.306
Device Catalogue Number02.107.306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
Treatment
2.7 METAPHYSEA SCR SLF-TPNG T8 SD REC/20; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 18; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 22; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 26; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 30; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 40; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX
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