• 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: DYNAMIC COMPRESSION 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: DYNAMIC COMPRESSION PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 3. 5mm dcp constructs/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 review of the following journal article: nasab s. , sarrafan n. , fakoor m. , mohammadzadeh m. ,(2013)comparison of volar and dorsal approaches for surgical treatment in fracture of proximal half of the radius, pakistan journal medical science volume 29(2), pages 532-535 (iran). This prospective study study aims to determine if there is a difference between anterior and posterior approaches in terms of complications or fracture union in the treatment of proximal half of radius fractures. Between 2008 and 2011,70 patients with proximal fractures of the forearm were evaluated and included in the study. Patients were divided into two groups. For the first group with fracture of radius, anterior approach, with 39 patients with mean age of 25. 31± 7. 34 years and for the second group, with 31 patients with mean age of 26 years posterior approach was employed. Orif with plate and screws (small dcp 3. 5mm) was performed. Clinical examination and radiography was performed at 4, 8, and 16 weeks after surgery. The following complications were reported as follows: in the dorsal approach group, two cases of radial nerve injury occurred, of whom, full recovery in one patient and partial recovery in the other one was seen after four months. 1 case of infection for dorsal approach group. In the patients with volar approach, injury to the sensory branch of radial nerve in one patient weakness in extension of the thumb and fingers was present in two patients at last follow-up. 1 case of infection for volar approach this report is for an unknown synthes small 3. 5mm dcp construct. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - CONSTRUCTS: DYNAMIC COMPRESSION 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 Key11572082
MDR Text Key257891452
Report Number8030965-2021-02336
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/26/2021
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: 03/25/2021 Patient Sequence Number: 1
-
-