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

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

Patient Problems Nerve Damage (1979); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, sex, weight: a total of 23 patients (10 male and 13 female).Brand name, common device name, procode, lot #, part #, udi #, 510k: this report is for an unknown synthes 3.5 mm locking compression plate/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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: páramo-díaz, p.Et al (2017), "surgical treatment of extra-articular distal-third diaphyseal fractures of the humerus using a modified posterior approach and an extra-articular plate." revista española de cirugía ortopédica y traumatología, vol.61 (6), pages 404-411 (spain).The purpose of this retrospective study is to assess the clinical and radiological outcomes obtained in our center after surgical intervention of the extra articular distal humerus fractures using a modified posterior approach as described by gerwin et al., with posterior osteosynthesis using a posterolateral extra articular distal humerus performed plate.Between 2013 and 2015, a total of 23 patients (10 male and 13 female) with a mean age of 45 years underwent a modified posterior gerwin approach and a posterolateral extra articular.In all cases the 3.5 mm lcp extra articular performed distal humerus plate was depuy synthes, west chester, pa, u.S.A.).The radiological outcome was also evaluated with regard to whether or not there had been displacement, and the presence or non-presence of consolidation was assessed every 1.5, 3, 6 and 12 months and the time during which this took place.The mean follow-up was 17.7 months and follow-up had been at least 1-year.The following complications were reported as follows: the article did not specify who among of the patients presented with radial palsy after surgery which was spontaneously resolved without the need for surgical revision.A (b)(6) patient had discomfort from the plate which limits the daily activities.This patient presented with radial palsy (plate and screw).Additional complications for this article are captured on related complaint (b)(4).This report is for an unknown synthes 3.5 mm locking compression plate.This is report 1 of 10 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8565346
• MDR Text Key: 143688169
• Report Number: 8030965-2019-63274
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 04/04/2019
• 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: 55 YR