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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank. This report is for one (1) unknown plate. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown plate. Pma/510(k) number is not available. (b)(4). Product was not returned. 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: korkmaz m. Et al (2008), the results of internal fixation of proximal humeral fractures with the philos locking plate, acta orthop traumatol turc, pages 97-105 ((b)(6)). The objective of this study was to evaluate the results of patients treated with the philos (proximal humeral internal locking system) locking plate. Between september 2005 and december 2007, a total of forty-one patients who has proximal humeral fractures were evaluated in two age groups. Fractures were treated with the philos plate. Reduction was attained by passing ethibond sutures. Patients were divided into two groups; patients who were below the age of 65 (group a) and patients with the age of 65 and above (group b). Group a consists 24 patients (12 males, 12 females; mean age 47 years; range 24 to 64 years) younger than 65 years, and group b involved 17 patients (4 males, 13 females; mean age 78 years; range67 to 90 years) at or above 65 years. All fractures were classified according to the ao/asif system radiographically. Surgery was performed with the deltopectoral approach in 10 and two patients, and with a deltoid split in 14 and 15 patients in group a and b, respectively. Functional and radiographic results were evaluated after a mean follow-up of 15 months (range 6 to 28 months). The following complications were reported as follows: (b)(6) female patient had intra-articular screw penetration and the screws that entered the joint were replaced by a deltoid split intervention after five months, and the defect in the head fragment was grafted with allograft as seen in figure 4. (b)(6) female patient had a displacement of the greater tuberculum as seen in figure 5. (b)(6) male patient experienced displacement of the tuberculum majus and the head was located on the varus and the plate was placed obliquely as seen in figure 6. 4 patients had insufficient reduction. 3 patients had varus displacement of the humeral head as seen in figure 7. This report is for an unknown synthes philos plate. This is report 2 of 7 for (b)(4). A copy of the literature article is being submitted with this medwatch.

 
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Type of DevicePLATE,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 Key8206617
MDR Text Key131727691
Report Number8030965-2018-59332
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeTU
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 12/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2018
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 Received12/07/2018
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: 12/31/2018 Patient Sequence Number: 1
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