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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 1 of 8 blockers.
 
Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device remains implanted.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.From the surgical technique guide: ¿foreign body sensitivity.Where material sensitivity is suspected, appropriate tests must be made prior to material selection or implantation.¿ the material of the blockers is titanium alloy: ti6al4v according to iso 5832-3 and astm f-136 which is composed of titanium, aluminum and vanadium.The above material specifications do not specify "nickel, chromium or cobalt" as a component.Allergic reactions to implants are most common with nickel, chromium, cobalt.Based on the information provided, it cannot be confirmed that described patient¿s symptoms are implant related, as the listed implants do not contain nickel, chromium, nor cobalt.The results of the patient¿s allergy testing was not provided.No revision surgery planned.
 
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 1 of 8 blockers.
 
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Brand Name
XIA 3 TITANIUM BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8728976
MDR Text Key149054091
Report Number3005525032-2019-00055
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540560193
UDI-Public04546540560193
Combination Product (y/n)N
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue Number48230000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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