MAUDE Adverse Event Report: ALPHATEC SPINE INC; KWP, MNH, MNI

Device Problems Break (1069); Fracture (1260); Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The identifying part and/or of numbers of the suspect implants are unknown and have not been provided.The user facility has not released the explanted devices.Upon the receipt of additional information or the product in question, a follow-up report will be submitted.The zodiac spinal fixation system facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.The implants are manufactured from surgical grade titanium alloy (ti-6al-4v eli or ti-6al-4v) or stainless steel (ss 316l).Implant rods are also available in commercially pure titanium (ti grade 4), titanium alloy (ti 6al 4v eli), stainless steel and cobalt chrome (co-28cr-6mo).All hooks are made from stainless steel (ss 316l) and titanium alloy (ti 6al 4v eli).The zodiac system is intended for fixation/attachment to the posterior thoracic and lumbar spine only.It is intended that the implants be removed after successful fusion.The zodiac system may be used in connection with alphatec spine's solanas posterior system, which in turn connects with avalon occipital plate system creating additional levels of fixation.

Event Description

Revision surgery was conducted on (b)(6) 2015 due hardware of a previously installed construct was found to contain both broken and/or backed out implants.Both zodiac rods located on the right and left sides of the t10-pelvis fractured and broke.The right side was broken at the s1 and the left at the l5.Both rods were removed and replaced.The patient had a nonunion fusion at both these area (l5-s1).Additionally, the polyaxial screw positioned within the l5 pedicle had also fractured and got broken.It was removed but not replaced.The 8.5mm set screw located on the left side of the iliac had backed-out of position.It was removed and replaced along with the right side that was found to be slightly loose.The zodiac spine fixation system was originally installed at the t-10-pelvis in (b)(6) 2014.

Manufacturer Narrative

An evaluation returned zodiac construct revealed no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released according to design specifications.The evaluation concluded no product problem exists.The 62001-50; ti alloy straight rod 5.5dia x 500mm, lot# 655081, mfg'd 4/18/2013.The 62065-40; ti standard polyaxial screw assy 6.5mm x 40mm, lot# 646204, mfg'd 4/18/2012.The 22085; zodiac ti hexalobe set screw, 8.5mm, lot# 672424, mfg'd 4/3/2014.Visual inspection revealed the polyaxial screw had fractured and broke mid-way of the threaded shaft.The rods contour had an aggressive curvature confirming they were both used in the lower lumbar spine where the greatest loads for implant systems are experienced.The fracture lines on the both rods are fairly perpendicular to the curvature which would indicate continual loading over time led to the fatigue of the material.Both the rods and anchor appear to have been exposed to fatigue stresses beyond those for which it was designed or intended.The patient was reported to have nonunion at the l5-s1 were both rods and the polyaxial screw fractures accrued.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 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.

• Type of Device: KWP, MNH, MNI
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 5001690
• MDR Text Key: 22909852
• Report Number: 2027467-2015-00164
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K033090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR