UNIII AXS SCREWS,AXS,ST,1.5X4MM,5/P 56-15034

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for UNIII AXS SCREWS,AXS,ST,1.5X4MM,5/P 56-15034 manufactured by Stryker Leibinger Freiburg.

Event Text Entries

[122304730] Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Screw body still in patient; screw head discarded at facility.
Patient Sequence No: 1, Text Type: N, H10


[122304731] It was reported by the company representative that the screw head broke off during insertion. The body of the screw was left in the patient. There was no adverse consequence nor delay of surgery reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2018-00095
MDR Report Key7920223
Date Received2018-09-28
Date of Report2018-11-16
Date of Event2018-09-17
Date Mfgr Received2018-09-17
Date Added to Maude2018-09-28
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 ContactMR. KELLI DYKSTRA
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER LEIBINGER FREIBURG
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer Postal CodeD-79111
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNIII AXS SCREWS,AXS,ST,1.5X4MM,5/P
Generic NameIMPLANT
Product CodeHBW
Date Received2018-09-28
Catalog Number56-15034
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER LEIBINGER FREIBURG
Manufacturer AddressBOETZINGERSTR. 41 FREIBURG D-79111 D-79111


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-28

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