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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 110MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 110MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48232110
Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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 the rod.
 
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 the rod.
 
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 rod is pure titanium: cp ti grade 4 according to iso 5832-2 and astm f-67.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.
 
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Brand Name
XIA 3 TITANIUM ROD DIAM 6MM CP TI L 110MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8714634
MDR Text Key148526812
Report Number3004024955-2019-00023
Device Sequence Number1
Product Code NKB
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 Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number48232110
Device Lot NumberAWS
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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