OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL UNILOCK-SCR 3 SELF-TAP L10 5U SCREW,FIXATION,BONE
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Catalog Number 413.580.05 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Malfunction
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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