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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 PERIARTIC PROX HUM PL 2 H/91/LT; PLATE, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP PERIARTIC PROX HUM PL 2 H/91/LT; PLATE, FIXATION, BONE Back to Search Results
Model Number 02.123.021
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 01/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Event year is reported as 2021; however the exact date of event is 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.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 or Problem Description
It was reported that on (b)(6) 2021 patient underwent revision surgery with bone grafting and a new proximal humerus plate and the associated screws for non union of proximal humerus, the primary surgery done in (b)(6) 2021.Previous hardware was intact, locking compression plate (lcp) and nine (9) unknown locking screws were removed successfully.There was patient consequence reported.This report is for one (1) 3.5mm lcp periarticular prox humerus pl 2 hole/91mm/lt.This is report 1 of 10 for complaint (b)(4).
 
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Brand Name
3.5 LCP PERIARTIC PROX HUM PL 2 H/91/LT
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11637726
Report Number2939274-2021-01746
Device Sequence Number3683899
Product Code HRS
UDI-Device Identifier10886982042057
UDI-Public(01)10886982042057
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K082625
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number02.123.021
Device Catalogue Number02.123.021
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/11/2021
Supplement Date Received by Manufacturer04/09/2021
Initial Report FDA Received Date04/08/2021
Supplement Report FDA Received Date04/09/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
Outcome Attributed to Adverse Event Required Intervention;
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