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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 Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. This report is for one (1) unknown plate. Pma/510(k) number is not available. 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.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent an unknown procedure using a philos implant. On an unknown date, that a patient experienced pain after pulling up his pants. An x-ray showed a broken plate. As per the surgeon, the philos plate and the implants worked well but since the patient had both broken poor, he could not spare enough and moved too early. Surgeon could not re-operate patient because it is not stable enough. Later, patient will undergo a revision with a humeral nail or a shoulder prosthesis. Patient outcome is unknown. Concomitant devices: screws (part unknown, lot unknown, quantity unknown). This report is for one (1) unknown philos plate. This is report 1 of 1 for (b)(4).
 
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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 Key8171176
MDR Text Key130553938
Report Number8030965-2018-59100
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
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 Received01/28/2019
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: 12/17/2018 Patient Sequence Number: 1
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