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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 Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown synthes 5-hole proximal humeral internal locking system (philos) plate/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. (b)(4). 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: kne¿evic´a, j. , mihaljb, m. , cukelja, f. And ivani¿evic´a, a. (2017), mipo of proximal humerus fractures through an anterolateral acromial approach. Is the axillary nerve at risk?, injury : international journal of the care of the injured, vol. 48 supplement 5, pages s15-s20 ((b)(6)). The aim of this prospective follow-up cohort study is to evaluate and compare the axillary nerve function before and after minimally-invasive plate osteosynthesis (mipo) for proximal humerus fractures between the non-injured and injured shoulders. Between february 2013 and november 2016, a total of 49 patients (16 male and 33 female) with a mean age of 62 years (range, 32-87 years) underwent minimally-invasive plate osteosynthesis. A 5-hole proximal humeral internal locking system (philos) plate (depuy synthes, (b)(4)) with angle-stable screw fixation and radiolucent aiming device was used in all cases. All patients underwent standardized electroneurographic testing, with full assessment of amplitudes of evoked compound muscle action potentials (cmap), in mv) and distal motor latencies (dml, in ms) of the axillary nerves before and after surgical treatment. The following complications were reported as follow: the author did not specify who among the patients were referred in (fig. 3) x-ray (d). Fixation failure and varus displacement. This report is for fixation failure and varus displacement. This report is for an unknown synthes 5-hole proximal humeral internal locking system (philos) plate. This is report 1 of 1 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 Key8198400
MDR Text Key131475234
Report Number8030965-2018-59262
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeHR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/03/2018
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: 12/27/2018 Patient Sequence Number: 1
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