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

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

Patient Problem Nerve Damage (1979)

Event Date 04/23/2013

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes philos plates/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.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.

Event Description

This report is being filed after the subsequent review of the following journal article: wu, x.Et al.(2013), long proximal humeral locking compression plate in the treatment of proximal humeral and humeral shaft fractures, chinese journal of tissue engineering research, vol.17, no.17, pages 3216-3222 (china).The purpose of this retrospective case analysis was to investigate the clinical effect of internal fixation of long proximal humeral locking compression plate on the treatment of proximal humerus and humeral shaft fractures.Between september 2008 and december 2010, 16 patients (7 males, 9 females with ages ranging from 45-83 years) who had proximal humeral fractures with humeral shaft fractures, who were treated with a synthes ao long proximal humeral internal locking system (philos) plate and screws, were included in the study.Follow-ups were done regularly at 1, 2, 3, 6, and 12 months postoperatively, and once a year thereafter.Complications were reported as follows: 2 patients developed fat liquefaction of the wound, which healed after dressing change.1 patient developed symptoms of radial nerve paralysis after treatment, and recovered after 4 weeks.1 patient developed shoulder peak impact syndrome that was given analgesia symptomatic treatment.This patient achieved only a satisfactory result according to the constant-murley scoring on the 12-month follow-up.He/she had poor reduction of the large nodules, and the shoulder joint impact syndrome had severely affected the functional exercises, and his/her shoulder joint function did not recover well although it improved after treatment.This report is for one patient who experienced radial nerve paralysis and for one patient who experienced shoulder peak impact syndrome (joint crepitation).This report is for an unknown synthes philos plates.This is report 1 of 2 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: 8401111
• MDR Text Key: 138146899
• Report Number: 8030965-2019-61813
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: 02/26/2019
• 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