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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL UNILOCK-SCR Ø3 SELF-TAP L10 5U SCREW,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL UNILOCK-SCR Ø3 SELF-TAP L10 5U SCREW,FIXATION,BONE Back to Search Results
Catalog Number 413.580.05
Device Problem Manufacturing, Packaging or Shipping Problem
Event Type  Malfunction  
Manufacturer Narrative

Occupation: initial reporter is synthes sales representative. Pma/510(k): device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 that on (b)(6) 2019, upon inspection of incoming goods by the distributor, a sternal unilock screw pack of five (5), only had four (4) screws inside the packaging were received. Another device was used to complete the surgery. There was no adverse consequences to the patient reported. This report is for one (1) sternal unilock-scr ø3 self-tap l10 5u. This is report 1 of 1 for (b)(4).

 
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Brand NameSTERNAL UNILOCK-SCR Ø3 SELF-TAP L10 5U
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8666409
Report Number8030965-2019-64846
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number413.580.05
Device LOT NumberH719926
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/19/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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