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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Edema (1820); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown plate. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for unknown plate. Pma/510(k) number is not available. (b)(4). Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and 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: natera cisneros, lg. And reiriz, js. (2017), acute high-grade acromioclavicular joint injuries: quality of life comparison between patients managed operatively with a hook plate versus patients managed non-operatively, european journal of orthopaedic surgery & traumatology, vol. 27(3), pages 341¿350 (spain). The aim of this retrospective cohort study is compare the qol of patients with acute high-grade acromioclavicular joint (acj) injuries managed operatively with hook plate versus the quality of life (qol) of patients managed non-operatively, 24 months or more after shoulder injury. Between january 1, 2008 and january 31, 2012, a total of 32 patients (29 male and 3 female) were included in the study. Patients were treated surgically by means of an open reduction and internal fixation with unknown synthes hook plates (plate group) consisted of 11 patients (11 male and 0 female) with a mean age of 41 years (range, 19-55 years) or conservatively (cons group) consisted of 21 patients (18 male and 3 female) with a mean age of 38 years (range, 19-55 years). Radiographic follow-up evaluations were based on the x-rays performed at the last follow-up. The minimum follow-up was 24 months after treatment decision. The following complications were reported as follow: 2 patients had incidence of scapular dyskinesis at the last follow-up visit. 4 patients had incidence of acromioclavicular joint (acj) dislocations at the last follow-up visit. 2 cases of subluxations were observed. 2 cases of complete dislocations were observed. 3 cases of calcification of the cc ligaments of the shoulders were observed. 3 cases of the lateral end of the clavicle showed osteolysis. 1 patient developed a severe pain several months after plate was removed. Mri was performed, 1 unknown case of an important subacromial edema was revealed and this was managed by means of a corticoid injection, and the symptoms subsided. 1 patient had surgical site infection that required a surgical debridement, and the breakage of a screw that could not be removed from the clavicle. This report is for an unknown hook plate. This is report 1 of 3 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key8272136
MDR Text Key133911899
Report Number8030965-2019-60226
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSP
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
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 Received01/04/2019
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: 01/23/2019 Patient Sequence Number: 1