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 Bone Fracture(s) (1870); Skin Irritation (2076); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate and screw construct/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.(b)(4).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: song, m.H.Et al (2019), nonoperative versus operative treatment for displaced midshaft clavicle fractures in adolescents: a comparative study, journal of pediatric orthopaedics b, vol.28 (1), pages 45¿50 (korea, south).The aim of this study is to investigate only adolescent displaced midshaft clavicle fractures, which recently have been considered relative operative indications, and to compare fracture outcomes and complications according to the treatment method in this age group.Between august 2010 to may 2015, a total of 41 patients (31 male and 10 female) with a mean age of 13.4 (10.4¿15.6) years were included in the study.Patients were grouped according to the nonoperative (n =23) or operative (n =18) treatment method.The patients with operative treatment underwent plate fixation using a 3.5-mm locking compression plate superior clavicle plate (synthes, paoli, pennsylvania, usa).All patients were followed for an average of 3.7 (2.1¿6.9) years.The following complications were reported: operative group: 2 patients showed delayed union.These patients achieved union at 16.7 and 20.1 weeks but did not require additional immobilization relative to other patients because the hardware acted as an internal fixator that held the fractured bones in place.1 patient complained of hardware irritation and required hardware removal.1 patient showed refracture secondary to additional trauma after hardware removal, and the fracture achieved union with figure-of-eight brace application for 5 weeks.1 patient had discomfort over the hypertrophic scar lesion.This report is for an unknown synthes plate/screws constructs.

• 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: 10718264
• MDR Text Key: 212563461
• Report Number: 8030965-2020-08110
• 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: foreign,literature
• Reporter Occupation: Physician
• 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: 10/22/2020
• 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