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

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.

Event Description

A physician reported that a patient was implanted with a xia 3 screw on (b)(6) 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.

Manufacturer Narrative

The device was reported to be an unknown xia 3 screw.No catalog or lot number were provided by the reporting hospital and the device was discarded.Neither a review of complaint history or device history records could not be performed without a valid lot number.Visual, dimensional, material, and functional analyses could not be performed because the device was not returned.It was reported that the decompression and fixation were performed using xia 3 for lcs on (b)(6) 2018.The implant was removed on (b)(6) 2018 due to infection.It was reported this patient later expired.Information regarding the type or cause of the infection was requested but not provided.According to the ifu: infection: transient bacteremia can occur in daily life.Dental manipulation, endoscopic examination and other minor surgical procedures have been associated with transient bacteremia.To help prevent infection at the implant site, it is advisable to use antibiotic prophylaxis before and after such procedures adverse effects: serious complications may be associated with any spinal surgery.These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, infection, paralysis or death.For safety reasons, non-sterile devices must be pre-cleaned, cleaned and sterilized prior to use.Moreover, for good maintenance, reusable instruments must be pre-cleaned, cleaned and sterilized immediately after surgery following the sequence of steps described in the following chart.It was reported that the patient expired due to an infection.It is unknown if the device contributed to the event and it there is no information provided that indicates that the device was caused or contributed to this event.Multiple follow-up attempts with the reporting hospital were performed and limited information was provided.If additional information becomes available in the future, that information will be provided in a supplemental report.

• Brand Name: XIA 3 SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9459759
• MDR Text Key: 170506975
• Report Number: 3005525032-2019-00089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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 Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR