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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 CLAV HK PL 6H 18 HK DPTH/73/RT-S PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S PLATE, FIXATION, BONE Back to Search Results
Model Number 241.096S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative

Additional 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 lateral fracture utilizing lcp clavicular hook plate 3. 5. Union was achieved after 16 weeks. Reoperation was done due to hardware removal; patient could feel implant. Concomitant devices reported: unk - screws: (part# unknown; lot# unknown; quantity: 6). This report is for one (1) 3. 5 lcp clav hk pl 6h 18 hk dpth/73/rt-s. This is report 1 of 7 for complaint (b)(4).

 
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Brand Name3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12387235
MDR Text Key268801084
Report Number2939274-2021-04999
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061753
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 Number241.096S
Device Catalogue Number241.096S
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
Treatment
UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
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