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

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

Patient Problems Discomfort (2330); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.Implant date is between may 2014 and may 2016.This report is for an unknown plate/ unknown lot.Part and lot number 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: bhardwaj, a., sharma, g., patil, a., and rahate, v.(2018), comparison of plate osteosynthesis versus non-operative management for mid-shaft clavicle fractures¿a prospective study, injury, vol.49, issue 6, pages, 1104-1107, (india).The aim of the study was to compare clinical and functional outcome between plate osteosynthesis and conservative line of management in middle-third clavicle fractures.Between may 2014 and may 2016, a total of 36 patients (8 males and 28 females) with closed clavicle fractures were treated with an lcp superior clavicle plate (depuy synthes, switzerland).The following complications were reported as follows: 1 patient had a malunion.1 patient had superficial infection which responded well to oral antibiotics.2 patients had plate prominence.1 patient had a fall 3 months after the surgery and had an implant breakage.This report is for an unknown synthes lcp superior clavicle plate.This report is for one (1) unknown plate.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - PLATES
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10697652
• MDR Text Key: 216602197
• Report Number: 8030965-2020-08041
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: 09/25/2020
• 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