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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Fatigue (1849); Pain (1994); Non-union Bone Fracture (2369); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown lcp constructs/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number 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 Description
This report is being filed after the review of the following journal article: prasarn, m. L. Et al. (2012), bisphosphonate-associated femur fractures have high complication rates with operative fixation, clinical orthopaedics and related research, vol 470, pages 2295-2301 (usa). Tha aim of this study is to determine whether there were: differences in osteoporosis and presence of the characteristic femur fracture in patients receiving bisphosphonate therapy versus an unmedicated cohort; and more complications in treatment of these fractures. Between 2002 and 2008, there were 45 patients who were divided into 2 groups; the biphosphonate group which had 25 patients and the control group which had 20 patients. All patients were female in the control group. Cephalomedullary nailing was considered first-line treatment for all fractures. Plate fixation (large-fragment locking plate) was used for revision surgery, if the femoral or fracture anatomy preoperatively was deemed sufficiently abnormal to preclude placement of a nail, or if required intraoperatively for adequate fracture reduction and fixation. Implants used were lcps. The minimum clinical followup was 5 months (mean, 29 months; range, 560 months). The following complications were reported as follows: major complications. Biphosphonate group. 3 out of 10 plate failures occured. None of the nails failed. 4 patients had implant failure. 1 patient had a nonunion. 1 patient had a malunion. Control group -1 female patient had a periprosthetic fracture minor complications biphosphonate group 1 patient had a heterotropic ossicfication. 2 patients had pain. 2 patients had weakness. 1 patient had sensory paresthesia. Control group 1 female patient had sensory pain. This report is for an unknown synthes lcp construct. It captures reported nonunion, malunion, heterotropic ossicfication, pain, weakness and sensory paresthesia. This is report 3 of 5 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11519605
MDR Text Key254802990
Report Number2939274-2021-01418
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/22/2021
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: 03/18/2021 Patient Sequence Number: 1
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