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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.211.034TS
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
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 germany reports an event as follows: it was reported on an unknown date that the screws cannot be removed from tubes. Related to fsn 1655109. No related surgery. No patient involvement. This complaint involves nine (9) devices. This report is for (1) 2. 7mm ti va lckng scr slf-tpng with t8 stardrive recess 34mm. This is report 5 of 6 (b)(4). Related product complaint: (b)(4).
 
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Brand Name2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM
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 Key10553680
MDR Text Key207545096
Report Number8030965-2020-07185
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K100776
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 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.211.034TS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? No
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: 09/18/2020 Patient Sequence Number: 1
Treatment
CORTSCR ø3.5 SELF-TAP L14 TAN; CORTSCR ø3.5 SELF-TAP L18 TAN; LOCKSCR A; LOCKSCR ø3.5 SELF-TAP L38 TAN
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