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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown nail head elements. Part and lot numbers are unknown; udi number is unknown. Investigation summary: video review: the received video confirm the issue as per event description that the dhs lag screw the slot is widened; the complaint therefore has been determined to be confirmed. Device history lot: null. Device history batch: null. Device history review: null. 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 reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 that an unknown date a video clip showed a malfunction with an unknown nail head elements. The pcf was closed since no further information is available to this social media report. Reporter saw this case on linkedin. No further information available. This complaint involves one (1) device. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
west chester, PA 19380
6107195000
MDR Report Key9745732
MDR Text Key191318755
Report Number8030965-2020-01345
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
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 Received02/02/2020
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

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