MAUDE Adverse Event Report: ALPHATEC SPINE INC ALPHATEC SOLUS LUMBAR SPACER; OVD

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

9 week post-op x-rays revealed the anterior blade of the solus spacer had not been deployed during the original surgery on (b)(6) 2014.Although there are early signs of union, it appears the implant may have moved slightly within the disc space but not enough to cause potential risk.There are no plans to remove the solus spacer which remains confined within the l5/s1 disk space.The patient is reported to be doing extremely well.

Manufacturer Narrative

An evaluation of the suspect device cannot be performed.The implant remains anchored within the patients l5/s1 vertebral body.The identifying part and/or lot numbers have not been provided.Upon the receipt of additional information a follow-up reported will be submitted.Instructions for use (ins-040): the alphatec solus anterior lumbar interbody fusion (alif) system is a stand alone anterior interbody fusion device that can also be used with supplemental fixation.It is an intervertebral body fixation system consisting of implants with various heights and lordosis to accommodate individual patient pathology.System implants are manufactured from implant grade polyetheretherketone (peek optima lt1), titanium (ti-6al-4v eli) anchoring blades and tantalum radiographic markers.System instruments are manufactured from stainless steel.Warnings: 4.Implant blades must be fully deployed into both vertebrae when implanted.Precautions 7.Bone density, quality, and/or stability may have adverse affects on the anchoring blades ability to be deployed or maintain purchase with the bone.

• Brand Name: ALPHATEC SOLUS LUMBAR SPACER
• Type of Device: OVD
• 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: 4129319
• MDR Text Key: 4796042
• Report Number: 2027467-2014-00030
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123993
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2014
• 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): Other
• Patient Age: 55 YR