MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 3.5 MM LCP OLECRANON PLATE; PLATE, FIXATION, BONE

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

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown precontoured 3.5 mm lcp olecranon plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: laun r., et al (2015), monteggia-like lesions ¿ treatment strategies and one-year results, gms interdisciplinary plastic and reconstructive surgery dgpw, volume 4, doc 13, pages 1-8 (germany) doi: 10.3205/iprs000072.This retrospective study aims to better define circumstances and patterns of injury and to document the short term results of treatment with current fixation techniques.Between 2012 and 2014, a total of 10 patients (4 male and 6 female) with an average age of 52.4 years (range, 18¿83 years) who underwent surgical treatment for a monteggialike lesion were included in the study.Osteosynthesis of the ulna was performed using a proximally contoured 3.5 mm lcp (locking compression plate) or pre-contoured 3.5 mm lcp olecranon plate (both synthes (b)(4), (b)(6)).Clinical and radiological follow-up examinations at an average of 12.3 months after the trauma were performed.The following complications were reported as follows: the average vas value was 1.0 (0 to 1) at rest and 1.7 (0 to 3) during activities.Two patients with a radial head prosthesis showed mild osteopenia and grade 1 degenerative changes.These patients exhibited grade 1 heterotopic ossifications.This report is for an unknown synthes precontoured 3.5 mm lcp olecranon plate.This is report 3 of 4 for complaint (b)(4).

• Brand Name: UNK - PLATES: 3.5 MM LCP OLECRANON PLATE
• 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: 8899262
• MDR Text Key: 154732929
• Report Number: 8030965-2019-67309
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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: 07/19/2019
• 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