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

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Loss of Range of Motion (2032); Scar Tissue (2060); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/ unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2011 to june 2016.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: yu, q.Et al.(2019), surgical treatment of avulsion fracture around joints of extremities using hook plate fixation, bmc musculoskeletal disorders, vol.20, number, 200, pages 1-7 (china), https://doi.Org/10.1186/s12891-019-2585-1.The purpose of the present study was to summarize clinical data of patients with avulsion fractures around joints of the extremities treated with hook plate fixation.More importantly, it was our goal to assess the necessity of surgery, the flaw of the mainstream internal fixation as well as the specific characteristics and therapeutic outcomes of hook plate.From january 2011 to june 2016, a total of 60 patients (35 males and 25 females) with a mean age of 43.7 (range 20 to 73 years) were treated with internal fixation using an ao hook plate.The following complications were reported as follows: in the last follow-up, 3 patients with avulsion fractures of the humeral greater tuberosity had shoulder joint adhesion and peri humeral inflammation, and the functional recovery of shoulder joint was poor.5 patients had mild joint fibrosis.35 patients had their internal fixation removed after 1 year of surgery.This report is for an ao hook plate.This report is for one unknown plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES
• 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: 9612957
• MDR Text Key: 189202176
• Report Number: 8030965-2020-00522
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• 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