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

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: leu th et al (2012)."clavicular hook plate: a better implant choice for fixation of unstable distal clavicle fractures?" journal of experimental and clinical medicine.Volume 4.Issue 5.Page 270-274 (taiwan).This retrospective study aimed to establish if clavicular hook plate is a better implant option for unstable distal clavicle fracture fixation.From january 2006 to december 2008, 45 patients with unstable distal clavicle fractures who received surgery were included in the study.The patients were divided into 2 groups based on the treatment method, the clavicle hook plate (hp) group and the k-wire and tension band wire (ktbw) group.The clavicle hook plate group included 25 patients (13 men and 12 women, mean age of 41.3 years (range: 17-85 years) ) who were implanted with an unknown ao modified stainless steel, curved, 3.5-mm dynamic compression plate.All patients were told to use a sling for the first 4 weeks to protect the operated shoulder.Gentle mobilization was allowed after the pain resolved.Patients were followed-up every month for the first 6 months and every 3 months thereafter.The average follow-up was 14.5 months (range: 12-25 months).In the hp group, all patients had their plates removed at a mean time of 5.8 months (range: 4-8 months).Complications were reported as follows: 1 patient had fracture that did not heal within 6 months.4 patients had symptomatic hardware.9 patients developed subacromial shoulder impingement (with positive neer¿s sign).These patients reported implant-related symptoms during shoulder mobilization including pain, a scraping feeling, or range of motion (rom) limitation caused by impingement.In all these patients, the impingement problems gradually resolved within 8 weeks of hardware removal.A (b)(6) man developed shoulder impingement syndrome after receiving hook plate fixation of a left distal clavicle fracture.At 90 degree forward elevation, abnormal superior translation of the humeral head with regard to the acromion obstructing its passage beneath the acromion was noted.A (b)(6) man had the hook portion disengaged from the acromion causing partial loss of reduction during x-ray at 4 weeks follow-up.A (b)(6) man patient experienced distal clavicle osteolysis as shown on the immediate x-ray after implant removal.This report is for one (1) device- an unknown ao clavicular hook plate.This is report 4 of 4 for (b)(4).

• 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: 8274048
• MDR Text Key: 133978753
• Report Number: 8030965-2019-60247
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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: 01/03/2019
• 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