SKYLINE CAM LOCKING * 2868-40-000 1205NT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-28 for SKYLINE CAM LOCKING * 2868-40-000 1205NT manufactured by Depuy Spine.

Event Text Entries

[2261784] Screw driver head broke while being used to implant cervical screw into plate. All pieces removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2273111
MDR Report Key2273111
Date Received2011-09-28
Date of Report2011-09-28
Date of Event2011-09-21
Report Date2011-09-28
Date Reported to FDA2011-09-28
Date Added to Maude2011-10-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSKYLINE CAM LOCKING
Generic NameCAM TIGHTENER SHAFT
Product CodeLRZ
Date Received2011-09-28
Model Number*
Catalog Number2868-40-000 1205NT
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2011-09-28

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