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

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

Patient Problems Arthritis (1723); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown clavicle hook plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone: (b)(6).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: bai-chuan, l.Et al (2009), postoperative complications of acromioclavicular joint dislocation of tossy iii, chinese journal of orthopaedic traumatology, vol.22 (2), pages 1-4 (china).The purpose of this study is to retrospectively analyze the postoperative complications of acromioclavicular joint dislocation (tossy iii) and explore the preventive methods for the complication.Between january 1997 and november 2007, a total of 54 patients were included in the study, 23 of these patients (17 male and 6 female) with an average age of (34.6 years) underwent open reduction and were treated with unknown ao synthes clavicular hook plate fixation.Patients were followed up, the follow-up time was 3 months to 3 years, and the average time was 18 months.The following complications were reported as follows: a (b)(6) male had loosening and pulling of some screws caused by improper chp screw fixation direction found in 8 weeks after the operation.A (b)(6) male had acromion cutting by the chp hook end part found in 8 weeks after the operation.A (b)(6) female had re-dislocation caused by acromion cutting by the chp hook end found in 5 weeks after the operation.1 patient had poor postoperative curative effect evaluation.2 patients had pain.2 patients had scapulohumeral periarthritis.1 patient had acromioclavicular arthritis.1 patient had impingement sign.2 patients had internal fixation failure.1 patient had unhooking.This report is for an unknown ao synthes clavicular hook plate.This is report 4 of 5 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8074045
• MDR Text Key: 127257494
• Report Number: 8030965-2018-58244
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/30/2018

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: 10/30/2018
• Initial Date FDA Received: 11/15/2018
• 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