MAUDE Adverse Event Report: ALPHATEC SPINE INC ZODIAC TI ALLOY STRAIGHT ROD 5.5MM X 50CM (TI-6AL-4V); MNH, MNI, KWP

Model Number 62001-50

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/14/2014

Event Type  Injury  

Event Description

An international customer (b)(6) reported that a patient returned to the doctor expressing she had been encountering some discomfort/pain.During the post-op visit, the surgeon found that the previously implanted 500mm zodiac rod had fractured and broken.Revision surgery to remove and replace the rod took place (b)(6), 2014.The patient is reported to be in good health.The zodiac degenerative spinal fixation system was originally implanted (b)(6), 2013.

Manufacturer Narrative

An evaluation of the suspect device found the implant was properly manufactured and released to design specifications.No irregularities have been identified.Due to the fact that the rod was implanted for over a year but was replaced as part of a revision surgery indicates the patient did not achieve fusion.The rod was contoured and had an aggressive curvature indicating it was used in the lower lumbar spine where the greatest loads for implant systems are experienced.The fracture pattern of the rod seems to indicate the crack initiated on the posterior side and then propagated through the rod over time.The fracture line is fairly perpendicular to the curvature which would indicate continual loading over time led to the fatigue of the material.Because the patient did not achieve fusion the construct was more than likely carrying the majority of the load throughout the time of implantation with no gradual transfer of load that would be associated with fusion.As these implants are intended for temporary stabilization until fusion occurs they do not have an indefinite useful life and will most likely fail over time if fusion is not achieved.The supplied instructions for use ( ins-025) warning states; warnings: the system implants are used only to provide temporary internal fixation during the bone fusion process with the assistance of a bone graft.A successful result may not be achieved in every instance of use with these devices.Without solid bone fusion, these devices cannot be expected to support the spine indefinitely and may fail due to bone-metal interface, rod failure or bone failure.The zodiac spinal fixation system is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine.It is intended to provide stabilization during the development of fusion utilizing a bone graft.Specific indications for the zodiac system are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

• Brand Name: ZODIAC TI ALLOY STRAIGHT ROD 5.5MM X 50CM (TI-6AL-4V)
• Type of Device: MNH, MNI, KWP
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: david mcgrath ; 5818 el camino real; carlsbad, CA 92008 ; 7604946936
• MDR Report Key: 3892440
• MDR Text Key: 4647005
• Report Number: 2027467-2014-00012
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K071890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2014

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?: Yes
• Device Operator: Physician
• Device Model Number: 62001-50
• Device Catalogue Number: 62001-50
• Device Lot Number: 651485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR