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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TRACTION,APPARATUS,NON-POWERED

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OBERDORF SYNTHES PRODUKTIONS GMBH TRACTION,APPARATUS,NON-POWERED Back to Search Results
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 510k: this report is for an unknown distractor /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn. Product was not returned. Device was used for treatment, not diagnosis.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, an unknown distractor broke. It was unknown when the issue occurred. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Type of DeviceTRACTION,APPARATUS,NON-POWERED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
3102 wrighs lane east
west chester, PA 19380
6107195000
MDR Report Key8025596
MDR Text Key125979916
Report Number8030965-2018-57794
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeFR
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 10/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2018
Is this an Adverse Event Report? No
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 Received10/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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