2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM 401.043

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-15 for 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM 401.043 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[145388974] Additional pro-code: jey. Occupation: synthes sales rep. A review of the device history record has been requested. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. The investigation could not be completed; 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.
Patient Sequence No: 1, Text Type: N, H10


[145388975] Device report from synthes reports an event in (b)(6) as follows: t was reported on (b)(6) 2019, during incoming goods checking, a titanium self-tapping cortex screw was noted to be missing in the sealed packaging. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2019-63990
MDR Report Key8613539
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-15
Date of Report2019-04-17
Date Mfgr Received2019-07-12
Device Manufacturer Date2018-07-26
Date Added to Maude2019-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal4436
Manufacturer Phone6103142063
Manufacturer G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM
Generic NameSCREW FIXATION INTRAOSSEOUS
Product CodeDZL
Date Received2019-05-15
Returned To Mfg2019-05-06
Catalog Number401.043
Lot NumberH693487
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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