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 Skin Irritation (2076); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown constructs: plate/screws/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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: kilinc, b.E., oc, y., and erturer, r.E.(2020), treatment of midshaft clavicle fracture with superior plate placement, acta ortopédica brasileira, vol.28 (2), pages 88¿91 (turkey).The aim of this retrospective case controlled study is to evaluate the late clinical and radiological results of patients who underwent locking plate fixation anatomically compatible in the superior surface and muscle cover on plate due to the mid-region of the clavicle.Between may 2009 to september 2016, a total of 40 patients (26 male and 14 female) with a mean age of 36.2 (range: 22-59) were included in the study.Surgery was performed using a 3.5 mm locking screw (lcp superior anterior clavicle plate) and a preformed clavicle plate with a low contact surface.The mean follow-up time was 36.4 months (range: 24-95).The following complications were reported as follows: 2 patients described the feeling of irritation due to the plate.7 patients were cosmetically disturbed by the incision scar.This report is for an unknown synthes plate/screws constructs.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: 10627775
• MDR Text Key: 209825163
• Report Number: 8030965-2020-07716
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

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: 09/24/2020
• Initial Date FDA Received: 10/05/2020
• 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