• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown narrow 3. 5mm lapping/dynamic compression plate construct/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.

 
Event Description

This report is being filed after the review of the following journal article: mahdi s, et al (2019) humeral shaft fracture: a randomized controlled trial of nonoperative versus operative management (plate fixation), orthopedic research and reviews volume 11,pages 141¿147 (iran) doi: 10. 2147/orr. S212998. This randomized clinical trial aims to compare clinical, functional, and radiological outcomes and the rate of complications among hsf patients treated with orif versus those receiving a functional sarmiento brace. Between january and december 2016, a total of 60 patients with isolated hsfs were included in the study. Patients were divided into two equal groups:30 patients (23 males, 7 females) age 37. 7±15. 4 years (18¿71 range) were in the operative treatment (orif) group, fixation was done using a narrow lapping/dynamic compression plate of 3. 5 mm and the non-operative group with 30 patients (26 males, 4 females) age 48. 5±19. 4 years (19¿77 range) using a functional brace called sarmiento. Patients were examined at the beginning of the study and weeks 2 and 4 after the treatment. The following complications were reported as follows: among the 30 eligible patients assigned to the operative group, 18 were identified with neuroapraxia that was transient and fully resolved within 3¿6 months of conservative management. This report is for an unknown synthes narrow 3. 5 mm lapping/dynamic compression plate construct. This is report 1 of 1 for complaint (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10871357
MDR Text Key217367354
Report Number8030965-2020-09094
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeIR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/19/2020 Patient Sequence Number: 1
-
-