MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482316540
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem 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 4 of 4 screws.
Additional 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 polyaxial screw 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 or Problem 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 4 of 4 screws.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8728980
• Report Number: 3005525032-2019-00051
• Device Sequence Number: 11227667
• Product Code: NKB
• UDI-Device Identifier: 04546540562234
• UDI-Public: 04546540562234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 482316540
• Device Lot Number: B71057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1