MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp superior clavicle plate/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.(b)(4).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: kim, h.Y.Et al.(2020), clinical and radiological outcomes after various treatments of midshaft clavicle fractures in adolescents, clinics in orthopedic surgery, vol.12, pages 396-403 (south korea) https://doi.Org/10.4055/cios20026.The purpose of this study was to compare the clinical and radiological outcomes of 4 different treatments for midshaft clavicle fractures in adolescents: conservative treatment with a figure-of-8 (fo8) brace, open reduction and internal fixation with a plate (opl), minimally invasive plate osteosynthesis (mipo), and intramedullary nail fixation with a threaded steinmann pin (tsp).From 2010 to 2015, a total of 49 patients with midshaft clavicle fractures underwent fixation using the lcp superior clavicle plate (depuy synthes, oberdorf, switzerland) and precontoured locking plate (acumed, hillsboro, or, usa).The article did not specify which of the devices were being used to capture the following complications: 7 patients had metal-induced irritating symptoms.2 patients had superficial skin infections.They were treated with antibiotics therapy without a surgical procedure.1 patient had supraclavicular nerve injury symptoms at the final follow-up.4 patients had refractures after plate removal.Three fractures were caused by another trauma at >3 months after metal removal.However, 1 refracture occurred within 6 weeks after plate removal.This report is for an unknown synthes lcp superior clavicle plate.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10730686
• MDR Text Key: 216610832
• Report Number: 8030965-2020-08147
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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
• Date Manufacturer Received: 09/28/2020
• 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
• Patient Outcome(s): Required Intervention