MAUDE Adverse Event Report: SEASPINE INC. VU APOD INTERVERTEBRAL BODY FUSION DEVICE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number 33-TA-3910

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2015

Event Type  malfunction  

Event Description

It was reported the device broke during a procedure.The implant cage cracked with minimal impaction during implantation.The surgeon noticed the threaded anterior portion of the implant had broken after minor impaction during his insertion of the implant.The failed implant was retrieved and a new construction was implanted.It was reported the patient was not injured.

Manufacturer Narrative

During the review of the dhr, it was concluded that the product was inspected and accepted for use on 8/9/2011 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.The implant was received with cracks at the inserter interface, most likely as a result of impaction from a hammer/mallet to position the device into the disc space while attached to the inserter.Based on a visual inspection of the devices, the fractures appear to be consistent with fracture of rigid plastic material, which can potentially occur if the device is subjected to load or impact creating greater stress than the material can withstand.There are more stress fractures vertically, which may suggest there might have been prying forces or off axis force applied at the time of failure.Due to the damage areas of the implant cannot be measured.The areas that can be measured met specifications.The root cause of the issue is unknown, but may be the result of some action by the user or anatomical conditions of the patient.Peek implants can fracture and may be the consequence or result of improper surgical technique (excessive force) or insufficient patient disc preparation or collapsed disc space allowing for proper insertion.There was no patient injury associated with this event.Review of labeling notes: warning cautions and precautions "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery" "surgical outcomes with this device are significantly affected by the surgeon's proper patient selection, preoperative planning, proper surgical technique, proper selection and placement of implants and complete compliance of the patient.Selection of the proper size, shape, and design of the implant for each patient is extremely important and crucial to the success of the procedure.Implants are subject to repeated stresses in use, and their strength is limited by the size and shape of the human spine.".

• Brand Name: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; 4900 charlemar drive; 4900 charlemar drive; carlsbad CA 92008
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5218233
• MDR Text Key: 31145217
• Report Number: 3004608878-2015-00283
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 33-TA-3910
• Device Lot Number: W16490
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2011
• 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