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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CURVED NARROW LCP PLATE/18 HOLES PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CURVED NARROW LCP PLATE/18 HOLES PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.161.218
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Malunion of Bone (4529)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, patient underwent a revision surgery due to non-union/malunion. Removal of 18 hole, 3. 5mm curved lcp plate from femur, as well as 6x 3. 5mm cortex screws was performed. A revision surgery was done, and the surgeon inserted an adolescent lateral entry femoral nail. This report involves one (1) 3. 5mm curved narrow lcp plate/18 holes. This is report 1 of 7 for (b)(4).
 
Manufacturer Narrative
Additional device product code: 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.
 
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Brand Name3.5MM CURVED NARROW LCP PLATE/18 HOLES
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
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key13978146
MDR Text Key288395835
Report Number2939274-2022-01152
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
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? No
Device Operator
Device Catalogue Number02.161.218
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
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
3.5MM CORTEX SCREW 26MM
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