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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US XIA 3 TITANIUM BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48230000
Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Difficult To Position (1467)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
Event Type  malfunction  
Event Description
It was reported that during a procedure, the tulip head on the screws was loose and would not take a blocker. One of the blockers that was tried, was severed at an angle. The two screws were taken out and replaced. There was a 30 minute surgical delay. There were no adverse health consequences to the patient.
 
Manufacturer Narrative
The customer reported event was confirmed via correspondence. The device was discarded at the hospital, so device inspection could not be performed. No lot number was provided, so a manufacturing record review could not be completed. Conclusion: per what was reported, not stryker product was used to tighten the blocker. According to the ifu, "stryker spine implants may only be implanted with the appropriate instruments supplied by stryker spine. Stryker spine shall not be liable for implants implanted using other manufacturer¿s instruments. " the most likely root causes are deviation from the surgical technique by using a non stryker spine torque wrench and possibly misalignment of the blockers during tightening. A definite root cause cannot be determined however as the devices were not returned for evaluation.
 
Event Description
It was reported that during a procedure, the tulip head on the screws was loose and would not take a blocker. One of the blockers that was tried, was severed at an angle. The two screws were taken out and replaced. There was a 30 minute surgical delay. There were no adverse health consequences to the patient.
 
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Brand NameXIA 3 TITANIUM BLOCKER
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
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allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
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la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7465104
MDR Text Key107206998
Report Number3005525032-2018-00030
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540560193
UDI-Public(01)04546540560193
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48230000
Device Catalogue Number48230000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
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

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