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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 Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

There are multiple patients. All known information is provided in the journal article. 510k: this report is for unknown plates/unknown lot. Part and lot number are unknown; udi number is unknown. Dates of implantation are unknown dates between 2005 and 2017. 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. (b)(4). 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: omlor, g. Et al enchondromas and atypical cartilaginous tumors at the proximal humerus treated with or without osteosynthesis: retrospective analysis of 42 cases with 6 years mean follow-up, world journal of surgical oncology 2018 pages 1-9 ((b)(6)). The objective of this study was to analyze the radiological, clinical, and functional outcome of this strategy and compare bone cement without osteosynthesis to bone cement compound osteosynthesis, which has not been analyzed so far. From 2005 till 2017, a total of 42 patients surgically treated for enchondroma or atypical cartilaginous tumors (act) at the proximal humerus were retrospectively analyzed. Of the 42 patients, 25 (4 male, 21 female) patients with mean age 50. 3 years, underwent rigorous intralesional excision with use of a high-speed burr and filling of the lesion with polymethyl-methacrylate bone cement (palacos r+g; heraeus medical, (b)(4)). Seventeen (8 male, 9 female) other patients with a mean age of 48. 2 years, underwent the same procedure, followed by the support of a proximal humerus compression plate (lcp; philos plate, synthes (b)(4)) in a way that the screws of the osteosynthesis were integrated into the bone cement as a compound plate osteosynthesis. All patients were followed until follow-up with information on surgeries, radiological outcome, clinical presentation in the outpatient clinic, recurrences, and complications. The mean follow-up was 73 months (range 8-224). The following complications were reported: 1 patient had peri-implant fracture which was related to a fall with adequate trauma. 1 patient had a postoperatively found intra-articular screw which needed a revision surgery. This report is for unknown synthes plates. This is report 1 of 2 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8202362
MDR Text Key131590302
Report Number8030965-2018-59292
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
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 Received12/05/2018
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: 12/28/2018 Patient Sequence Number: 1
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