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); No Code Available (3191)

Event Date 01/11/2012

Event Type  Injury  

Manufacturer Narrative

This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plate.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: d.Tiren, a.J.M.Van bemmel, d.J.Swank, f.M.Van der linden (2012).Hook plate fixation of acute displaced lateral clavicle fractures: mid-term results and a brief literature overview.Journal of orthopaedic surgery and research.Page 1-8.(the netherlands).The purpose of this study is to evaluate the results and long term effects in use of this plate.From 2001 to 2008, 28 consecutive patients with acute displaced lateral clavicle fractures, treated with the clavicle hook plate were included in this retrospective analysis.Mean age was 38 years (range 15-64), male to female ratio was 21 to 7.Fourteen patients had a right sided and fourteen had a left-sided fracture.All patients had an edinburgh type 3b1/ neer type ii fracture.All patients had suffered a monotrauma.The clavicle hook plate used in this study is a pre-contoured stainless steel, dynamic compression plate with a wider anterolateral end and a lateral extension into a hook which is placed below the acromion.Objective and subjective shoulder function evaluation was performed with the dash and constant-murley scoring systems after which patients were radiographically assessed.After a mean follow up of 6 months (range 2-14 months), the plate was removed under general anesthesia.The following complications were reported as follows: (all seen in table 1).Patient 2 - (b)(6) year-old male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 4 - (b)(6) year-old male had acromioclavicular joint arthrosis seen in the x-ray.Patient 6 - (b)(6) year-old male had plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 7 - (b)(6) year-old female underwent plate removal due to impingement.Patient 8 - (b)(6) year-old female had subacromial osteolysis seen in the x-ray.Patient 10 - (b)(6) year-old male had extra-articular ossification seen in the x-ray.Patient 11 - (b)(6) year-old male underwent plate removal due to pain.This patient was diagnosed with acromioclavicular joint arthrosis and had to undergo lateral clavicle resection.Patient 13 - (b)(6) year-old male underwent plate removal due to impingement.Patient 14 - (b)(6) year-old male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 18 - (b)(6) year-old male had acromioclavicular joint arthrosis as seen in the x-ray.Patient 19 - (b)(6) year-old male had wound infection; subacromial osteolysis was also seen in the x-ray.Patient 21 - (b)(6) year-old male underwent plate removal due to impingement and acromioclavicular joint arthrosis was seen in the x-ray.Patient 22 -(b)(6) year-old male underwent plate removal due to impingement; poliomyelitis and extra-articular ossification were also seen in the x-ray.Patient 24 - (b)(6) year-old female had nonunion as seen in the x-ray.Patient 25 - (b)(6) year-old female underwent plate removal due to impingement.Patient 26 - (b)(6) year-old male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.This report is for unknown dynamic compression plate (dcp) clavicle hook plate.This is report 7 of 10 for (b)(4).The complaint involves 16 devices.Due to a system limitation, (b)(4) captures ten (10) devices and (b)(4) captures six (6) devices.

• 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: 8239953
• MDR Text Key: 132805597
• Report Number: 8030965-2019-59786
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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: 01/07/2019
• 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
• Patient Age: 44 YR