2.0MM IMF SCREW SELF-DRILLING 8MM 201.928

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 2019-02-28 for 2.0MM IMF SCREW SELF-DRILLING 8MM 201.928 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[137410652] Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: initial reporter is a synthes sales consultant. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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


[137410653] Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent an unknown procedure. During the procedure, the holding sleeve of the intermaxillary fixation (imf) screw did not hold the head of the screws well; when the screws were placed they move a lot, making placement difficult. It was noted a lot of force was placed on two (2) self-drilling intermaxillary fixation (imf) screws to place them. It is unknown if there was a surgical delay. Procedure outcome and patient status were unknown. This report is for an intermaxillary fixation (imf) screw. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2019-61546
MDR Report Key8377909
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-28
Date of Report2019-02-05
Date of Event2019-02-05
Date Mfgr Received2019-02-05
Date Added to Maude2019-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
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 IMF SCREW SELF-DRILLING 8MM
Generic NameSCREW FIXATION INTRAOSSEOUS
Product CodeDZL
Date Received2019-02-28
Model Number201.928
Catalog Number201.928
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-28

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