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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP ANGULAR STABLE PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: LCP ANGULAR STABLE PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthritis (1723)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown plates: lcp angular stable/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: vasyuk v. L. , koval o. A. , (2018) closed minimally invasive osteosynthesis of metaepiphyseal fractures of the distal tibial bones, trauma volume 19, no 5, pages 1-12 (ukraine). This study aims to improve the results of surgical treatment of distal tibial metaphyseal fractures by developing, substantiating, and implementing an improved technique of minimally invasive osteosynthesis. During the period from 2007 to 2017, 342 patients (206 males, 136 female) with fractures of the distal segment of the leg bones were operated on in the clinic of the bukovinian state medical university¿s academic department of traumatology and orthopedics. Of these, fractures of the osteosynthesis was performed in 265 patients using the following plates: clover-shaped plate ¿ 63 patients, l-shaped lcps (with angular stability) ¿ 21 patients, wires ¿ 57 patients, efa ¿ 19 patients, efa + wires ¿ 14 patients, efa + plates ¿ 23 patients, efa for small segments ¿ 68 patients. The patients were divided into clinical groups depending on the type of surgery: clinical group i included patients treated with minimally invasive screw-wire osteosynthesis (113 patients with 51 females and 62 males), patients over 60 years old prevailed ¿ 33 patients. The next age groups were: 30¿40 years old (22 patients), 50¿60 years old (21 patients). Clinical group ii included patients treated with efa osteosynthesis (36 patients with 14 females and 22 males with a median age of 46. 05 years), and clinical group iii included patients treated with plate osteosynthesis (116 patients with 49 females and 67 males with median age of 41. 76 ± 15. 04 years). The following complications were reported as follows: clinical group iii: a significant number of patients showed degenerative changes in bone tissue, the phenomena of post-traumatic arthrosis, and persistent contractures of the ankle joint. A case of patient l born in (b)(6), was admitted to the trauma department for adults on 05/17/2010 with the diagnosis: closed comminuted spiral fracture of the distal metaepiphysis of both bones of the right tibia with a displacement of fragments 43-a3. 3. The patient underwent osteosynthesis of the right tibia with a plate with angular stability, a reconstructive plate, and screws, osteosynthesis of the fibula with a reconstructive plate. The long-term result after 8 years the patient was diagnosed with persistent contracture of the ankle joint, post-traumatic osteoarthritis of the third stage. This report is for unknown synthes l-shaped lcps (with angular stability).

 
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Brand NameUNK - PLATES: LCP ANGULAR STABLE
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12366423
MDR Text Key268094633
Report Number8030965-2021-07188
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received07/28/2021
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

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