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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 Unspecified Infection (1930); Necrosis (1971); Non-union Bone Fracture (2369); Malunion of Bone (4529); Insufficient Information (4580)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: this report is for an unk - constructs: plate/screw unknown lot. Part and lot numbers are unknown; udi 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: ranson, r. Et al. (2021), no change in outcome ten years following locking plate repair of displaced proximal humerus fractures, european journal of orthopaedic surgery & traumatology, vol. Xx, pages 1-6 (usa). The purpose of this study was to assess for longer-term outcomes following proximal humerus fracture repair by comparing outcomes at oneand minimum 5-year follow-up following locking plate and screw fixation of proximal humerus fractures. From 2003 to 2015, a total of 75 patients were treated operatively for proximal humerus fractures with an anatomic locking plate (synthes, (b)(4) exactech, (b)(4) and stryker (b)(4)). The mean age was 10. 0 ± 3. 2 years follow-up (range 5. 0¿16. 8 years) patient follow-up information and functional score data were collected at 3 months, 6 months, 12 months, and annually thereafter as needed. The article did not specify which of the devices were being used to capture the following complications: the following complications were reported as follows: reoperations (n
=
13), screw penetrations (n
=
11), avn (n
=
7), infections (n
=
3), malunions of the greater tuberosity (n
=
3), fracture nonunions (n
=
2). 1 patient underwent removal of implant and soft-tissue mass excision at 5 years following development of an unrelated benign neoplasm. 1 patient underwent removal of implant 2 years after initial fixation as part of a procedure that included a capsular release to improve motion. The same patient had an unrelated fall down stairs that resulted in a shoulder dislocation with a bankart lesion and labral tear. She then required a latarjet procedure 6 years after initial fracture fixation to correct recurrent shoulder instability that resulted from that event. 1 patient underwent implant removal and rotator cuff repair 6 years post-operatively resulting from a second fall and dislocation. 1 patient underwent implant removal 3 years post-operatively for painful hardware without further complication. This report is for an unknown synthes anatomic locking plate. This is report 1 of 1 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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15116486
MDR Text Key296748183
Report Number2939274-2022-02975
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 Literature,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 Received07/27/2022
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
Date Manufacturer Received06/29/2022
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: 07/27/2022 Patient Sequence Number: 1
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