MAUDE Adverse Event Report: ALPHATEC SPINE INC 5.5MM UNIPLANAR SCREW, 45MM (TI-6AL-4V); KWP, MNI, MNH

Model Number 22055-45

Device Problems Bent (1059); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

An international customer ((b)(6)) reported an incident involving a zodiac uniplanar screw.The event occurred during a deformity (idiopathic scoliosis) case on (b)(6) 2014.During the final tightening process the head/tulip of the zodiac uniplanar screw located at the l2 bent and cracked preventing torquing of the set screw.The splayed head/tulip did not detach from the body of the uniplanar screw, it remains positioned at the l2 vertebral body.

Manufacturer Narrative

No product evaluation can be conducted.The splayed/bent uniplanar screw remains secured within the patients l2 vertebral body.A review of the device history record did not reveal any anomalies.The uniplanar screw was properly manufactured and released according to design specifications.Based on the supplied photo and what was described in the report, it appears the axial reducer may not have been completely attached and when the forces were placed on the screw during the de-rotation maneuver.If the instrument (axial reducer) is not attached appropriately with good alignment the setscrew may be slightly misaligned which could potentially lead to a cross threading of the setscrew.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: 5.5MM UNIPLANAR SCREW, 45MM (TI-6AL-4V)
• Type of Device: KWP, MNI, MNH
• 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: 3961105
• MDR Text Key: 4627083
• Report Number: 2027467-2014-00022
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K100685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 22055-45
• Device Catalogue Number: 22055-45
• Device Lot Number: 659514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• 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): Other
• Patient Age: 12 YR