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

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).

• Brand Name: UNK - PLATES: LCP ANGULAR STABLE
• Type of Device: PLATE,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 Key: 12366423
• MDR Text Key: 268094633
• Report Number: 8030965-2021-07188
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1