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


  • 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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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: leu th et al (2012). "clavicular hook plate: a better implant choice for fixation of unstable distal clavicle fractures?" journal of experimental and clinical medicine. Volume 4. Issue 5. Page 270-274 (taiwan). This retrospective study aimed to establish if clavicular hook plate is a better implant option for unstable distal clavicle fracture fixation. From january 2006 to december 2008, 45 patients with unstable distal clavicle fractures who received surgery were included in the study. The patients were divided into 2 groups based on the treatment method, the clavicle hook plate (hp) group and the k-wire and tension band wire (ktbw) group. The clavicle hook plate group included 25 patients (13 men and 12 women, mean age of 41. 3 years (range: 17-85 years) ) who were implanted with an unknown ao modified stainless steel, curved, 3. 5-mm dynamic compression plate. All patients were told to use a sling for the first 4 weeks to protect the operated shoulder. Gentle mobilization was allowed after the pain resolved. Patients were followed-up every month for the first 6 months and every 3 months thereafter. The average follow-up was 14. 5 months (range: 12-25 months). In the hp group, all patients had their plates removed at a mean time of 5. 8 months (range: 4-8 months). Complications were reported as follows: 1 patient had fracture that did not heal within 6 months. 4 patients had symptomatic hardware. 9 patients developed subacromial shoulder impingement (with positive neer¿s sign). These patients reported implant-related symptoms during shoulder mobilization including pain, a scraping feeling, or range of motion (rom) limitation caused by impingement. In all these patients, the impingement problems gradually resolved within 8 weeks of hardware removal. A (b)(6) man developed shoulder impingement syndrome after receiving hook plate fixation of a left distal clavicle fracture. At 90 degree forward elevation, abnormal superior translation of the humeral head with regard to the acromion obstructing its passage beneath the acromion was noted. A (b)(6) man had the hook portion disengaged from the acromion causing partial loss of reduction during x-ray at 4 weeks follow-up. A (b)(6) man patient experienced distal clavicle osteolysis as shown on the immediate x-ray after implant removal. This report is for one (1) device- an unknown ao clavicular hook plate. This is report 4 of 4 for (b)(4).
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8274048
MDR Text Key133978753
Report Number8030965-2019-60247
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
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 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
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 Received01/03/2019
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: 01/24/2019 Patient Sequence Number: 1