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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 02.200.014TS
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2020
Event Type  malfunction  
Manufacturer Narrative
Additional product code hwc. Reporter is jnj representative. 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 an unknown date, the sterile tube did not open accordingly. It was unknown if the surgery completed successfully without delay. It was also unknown that if there any fragments generated. There were no patient consequences reported. This complaint involves eight (8) devices. This report is for (1) 3. 5mm stardrive cortex screw self-tapping 14mm. This is report 7 of 8 for (b)(4).
 
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Brand Name3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10309377
MDR Text Key199917813
Report Number8030965-2020-05135
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K131186
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 07/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.200.014TS
Device Lot Number6L28349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/22/2020 Patient Sequence Number: 1
Treatment
CANCELLOUSSCR A
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