MAUDE Adverse Event Report: ALPHATEC SPINE INC SD - PEEK MEDIUM SPACER - 9MM X 25MM X 9MM (PEEK); MQP

Model Number 64815-009

Device Problems Fracture (1260); Material Fragmentation (1261); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

An international customer ((b)(6)) reported that during the case the surgeon confirmed the novel peek cage had not been properly position within the l5 vertebral body.The surgeon connected the cage driver and extracted it with a hammer.During removal the peek cage fractured into two separate sections.One, the threaded section remained attached to the removal instrument and the second section was removed using kocher forceps.Despite gathering the both sections of the fractured cage, it's highly possible that fragments may remain within the patient.No health injury of the patient was confirmed.

Manufacturer Narrative

Visual inspection found that the cage had fractured and broke just below the id threads where the inserter attaches/mates.The failure mode indicates that upon removal, the surgeon may have shimmied/wiggled the implant in order to free it from a tight disk space placing excessive load on the device which introduced stress/forces it was not designed to withstand.A review of the device history record revealed no anomalies.The returned peek cage was properly manufactured and released according to design specifications.The novel spinal spacer system is an intervertebral body fusion device that can also be used as a vertebral replacement device.The implants are a spinal fixation system consisting of various cylindrical shapes (footprints) of varying lengths, widths and heights to accommodate individual patient pathology.System implants are manufactured of surgical grade titanium alloy (astm f-136) or polyetheretherketone, peek (astm f-2026).A radiographic marker made of titanium (astm f-136) or tantalum (astm f-560) facilitates visualization.The novel spinal system must be used with a supplemental spinal fixation system.Specifically, the novel spinal spacer system should be used with the alphatec zodiac® polyaxial system.The novel spinal spacer system as a cervical intervertebral body fusion device should be used with the alphatec trestle® spinal system.When used as an intervertebral body fusion, the novel spinal spacer system is to be used with autogenous bone graft and these patients should have had six months of non-operative treatment.

• Brand Name: SD - PEEK MEDIUM SPACER - 9MM X 25MM X 9MM (PEEK)
• Type of Device: MQP
• 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: 4649451
• MDR Text Key: 5597274
• Report Number: 2027467-2015-00059
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050553
• 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: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 64815-009
• Device Catalogue Number: 64815-009
• Device Lot Number: 681448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• 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