MAUDE Adverse Event Report: ALPHATEC SPINE INC TI CANNULATED POLYAXIAL SCREW 5.5 MM X 40 MM (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number 73855-40

Device Problems Entrapment of Device (1212); Fracture (1260)

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

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

The international customer provided two (2) separate identifying lot numbers.It is unknown which belongs to the fractured polyaxial screw.Lot 675892 manufactured 6/4/2014, lot 694435 manufactured 7/16/2015.Although an evaluation of the implant is not possible, it was reported that the patient had achieved fusion/healing.This indicates the failure most likely occurred after providing the necessary stabilization to allow the patient to achieve fusion.It appears that the anchor was likely exposed to fatigue stresses beyond those for which it was designed or intended.The provided instruction for use (ins-028) state; indications for use: the illico mis posterior fixation system is intended for posterior, non-cervical, spinal fixation device in skeletally mature patents as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.E., fracture or dislocation); spinal stenosis; curvatures (i.E., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.It is intended that this device, in any system configuration, be removed after development of solid fusion mass.Postoperative management: 5.The illico mis posterior fixation system implants are designed and intended as temporary fixation devices.The devices should be removed after complete healing has occurred.Devices, which are not removed after serving their intended purpose may bend, dislocate, or break and/or cause corrosion, localized tissue reaction, pain, infection, and/or bone loss due to stress shielding.Complete postoperative management to maintain the desired result should also follow implant removal surgery.

Event Description

Since the patient had achieved fusion/healing, the surgeon decided to remove the illico construct which had been implanted in (b)(6) 2016.While conducting a preoperative exam on (b)(6) 2017, images revealed the cannulated screw located at the right l1 had fractured and broke.During removal ((b)(6) 2018), the proximal section was removed and unfortunately thrown out.The distal threaded portion of the anchor remains entrapped within the patients lumber vertebrae (l1).

• Brand Name: TI CANNULATED POLYAXIAL SCREW 5.5 MM X 40 MM (TI-6AI-4V ELI)
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7267060
• MDR Text Key: 99937613
• Report Number: 2027467-2018-00002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123623
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 73855-40
• Device Catalogue Number: 73855-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 27 YR