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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 4823717580
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2016
Event Type  malfunction  
Event Description
It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.
 
Manufacturer Narrative
Unanticipated hazard.Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The reported event occurred while doctor was using a standard blocker inserter.No persuader was being used by the surgeon according to communication with the sales representative.Surgical technique states the blocker is assembled onto the universal tightener for insertion.Conclusion: a definitive root cause of the event could not be determined with the given information.
 
Event Description
It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH   2300
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5648310
MDR Text Key46017973
Report Number3005525032-2016-00052
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613252045793
UDI-Public(01)07613252045793
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number4823717580
Device Lot NumberB33429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2016
Initial Date FDA Received05/11/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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