MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CALIX LUMBAR SPINAL IMPLANT SYSTEM; LUMBAR SPINAL FUSION IMPLANT SYSTEM

Model Number X034-0002

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Device not received by manufacturer.

Event Description

Reported via phone and e-mail; the (b)(6)hospital in (b)(6) and dr.(b)(6), who operates there, reported via the distributor, (b)(6), that the hospital is experiencing 'an infection problem' and 'having issues with their sterilization and validation process'.Of ten patients reported to have shown large wound infections, possibly caused by a pseudomona bacteria, this report is for one of those patients.This patient is reported to have had a large infection at the surgical wound site, with one revision surgery to remove the calix implant and infectious matter from around the implant site.This patient was treated with unspecified antibiotics before and after the revision at an unspecified dosage.It is estimated that the length of stay at the hospital has been approximately one to two weeks, but the exact dates were not given.This patient was also reported to be over (b)(6), weak due to the revision surgery and blood loss, and may have pneumonia.

Manufacturer Narrative

Initial mdr # 3005031160-2015-00012.While calix and fortex trays were returned and available for investigation on 10/30/2015, the explanted calix implants were not returned within the trays.Each tray was inspected as part of the complaint investigation.Not evaluated reason: device not received by mfr.

Event Description

It was reported that by (b)(6) 2015, the last pt had left the hospital.No new cases of infection associated with the calix tlif system have been reported from the hospital in leer via surgico.The complete consignment warehouse of calix surgical trays, and add'l fortex surgical trays, were received by the mfr, x-spine systems, the devices were not available for investigation until 10/30/2015.No explanted calix implants were returned for eval by the complainant or received by the mfr x-spine.Within the returned g23 f fortex surgical tray six (6) pedical screws were found to have possible signs of use upon eval.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Type of Device: LUMBAR SPINAL FUSION IMPLANT SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: kriss anderson ; 452 alexandersville rd.; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 5071350
• MDR Text Key: 25574032
• Report Number: 3005031160-2015-00012
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: X034-0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention