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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 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 482316545
Device Problems Fracture (1260); Mechanical Problem (1384); Difficult to Remove (1528); Component Missing (2306)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 09/16/2015
Event Type  Injury  
Event Description
It was reported that; during a revision operation of a plif, 2 screws fractured.Initially there was a fusion at l4-l5, dating from (b)(6) 2014.It was now decided to also do a plif at l5-s1.1 piece of the screw remained in the patient, it was impossible to remove due to the location of the missing part.A delay of 30 minutes in the surgery was reported.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: inspection of the device revealed beach marks on the fracture surface, which is consistent with fatigue fracture.Conclusion: the most likely cause of the event is fatigue fracture due to normal loads imposed by the body.
 
Event Description
It was reported that; during a revision operation of a plif, 2 screws fractured.Initially there was a fusion at l4-l5, dating from (b)(6) 2014.It was now decided to also do a plif at l5-s1.1 piece of the screw remained in the patient, it was impossible to remove due to the location of the missing part.A delay of 30 minutes in the surgery was reported.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
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 Key5145540
MDR Text Key28074304
Report Number3005525032-2015-00124
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Followup
Report Date 09/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number482316545
Device Lot NumberB42110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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