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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 482315550
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/13/2016
Event Type  malfunction  
Event Description
It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update 16-may-2016: ct images of broken screws available.
 
Manufacturer Narrative
Complaint history review; risk assessment.No lot # was provided, so a manufacturing record review could not be performed.The device has not been returned for inspection, the activity level of the patient is unknown.It is unknown if the patient experienced any fall and the date of initial surgery is not known.The root cause of the event could not be determined with the given information.
 
Event Description
It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update (b)(6) 2016: ct images of broken screws available.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 50 MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
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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 Key5707581
MDR Text Key48026252
Report Number3005525032-2016-00064
Device Sequence Number1
Product Code MNI
UDI-Device Identifier04546540562067
UDI-Public(01)04546540562067
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
Type of Report Initial,Followup
Report Date 05/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number482315550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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