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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
Catalog Number 48230000
Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)
Patient Problem Itching Sensation (1943)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
Physician reported ¿a patient implanted in (b)(6) 2017 with ¿screws and rod¿ has developed a generalized pruritus that does not disappear since the implantation. ¿ the physician suggests the patient may have an allergy to a component of the device. Details of specific medical intervention have not been provided and the patient has consulted with a dermatologist. This record represents 6 of 8 blockers.
 
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Brand NameXIA 3 TITANIUM BLOCKER
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
margarita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8728991
MDR Text Key149052320
Report Number3005525032-2019-00060
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540560193
UDI-Public04546540560193
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number48230000
Device Lot NumberUNKNOWN
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 Received07/26/2019
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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