MAUDE Adverse Event Report: ALPHATEC SPINE INC LLC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 25MM X 10MM; MQP

Model Number 64115-110

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/27/2014

Event Type  Injury  

Event Description

While attempting to implant a 10mm peek cage via impaction, the cage fractured and cracked at the inserter/cage interface.The fractured allowed the spacer to separate from the inserter and fall into the patient's disk space resulting in a dura leak.The implant was removed from the disk space and the dura tear sutured/repaired without further issue.

Manufacturer Narrative

Additional information provided by the sales rep indicated trials were not used, the disk height and length were determined by rotary shavers.An evaluation of the suspect device revealed no irregularities.It appears instrumentation misuse as the most likely cause of the failure.This surgical case was reported to have proceeded without the use of implant size trials to determine the correct size implant prior to placement.Mallet impaction was then utilized to maneuver the implant into position.As a result, loads exceeding the ultimate strength of the implant were applied causing the implant to fail.Surgical technique (lit-83193) instructs the user to insert a trial upon completion of endplate preparation to confirm the correct disk height.Trials are closely matched to the height, lordosis and footprint of the implant.Trials should be used when deciding the appropriate implant to use during surgery.These trials are designed to minimize the risk of damage to the implants during a procedure while also helping the surgeon to identify the best implant to use.

• Brand Name: LLC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 25MM X 10MM
• Type of Device: MQP
• 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: 3947628
• MDR Text Key: 4601895
• Report Number: 2027467-2014-00020
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: K050553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 64115-110
• Device Catalogue Number: 64115-110
• Device Lot Number: 672696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2014
• 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