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U.S. Department of Health and Human Services

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

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STRYKER SPINE-US XIA 3 SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Date 06/01/2018
Event Type  Death  
Manufacturer Narrative
To date, no other information has been provided by the complainant. The cause of the patient's infection and the relation of the infection to the device is unknown. The cause and exact date of the patient's death is unknown. Additional information has been requested and an investigation is underway. A supplemental report will be filed upon receipt of additional information and/or completion of the investigation. Device will not be returned for evaluation.
 
Event Description
A physician reported that a patient was implanted with a xia 3 screw on 31 may 2018. No complications during the initial surgery were noted. The patient experienced a post-operative infection and the device was explanted on (b)(6) 2018. On (b)(6) 2019, it was reported that the patient has died. The xia 3 device was not implanted at the time of the patient¿s death.
 
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Brand NameXIA 3 SCREW
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
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key9459759
MDR Text Key170506975
Report Number3005525032-2019-00089
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNK_SPN
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 Received02/29/2020
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

Patient Treatment Data
Date Received: 12/12/2019 Patient Sequence Number: 1
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