MAUDE Adverse Event Report: SEASPINE INC. SEASPINE SPACER SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 34-5110

Device Problems Fracture (1260); Material Fragmentation (1261); Difficult To Position (1467)

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

Event Date 09/02/2015

Event Type  malfunction  

Event Description

It was reported the device broke into four pieces during a surgery.The implant was placed in the interbody space at l4-5 and the inserter was removed.The implant then broke while being positioned with the pusher device that comes standard in the set.The surgeon stated that the implant was not impacted very hard at all with the pusher and he was surprised that it broke so easily.The broken implant was removed and replaced with another implant without incident.The surgery was delayed less than 10 minutes.The patient was not harmed.The broken implant was sent to sterile processing for cleaning.

Manufacturer Narrative

During the review of the dhr, it was concluded that the product was inspected and accepted for use on (b)(6) 2014 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.The implant was received in three pieces, fractured laterally, most likely as a result of hammering the side of the implant with the pusher to reposition the device laterally across the disc space.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.The proximal insertion point is intact and doesn't appear to be the point of impact.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: SEASPINE SPACER SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; 22 terry avenue; 22 terry avenue; carlsbad CA 92008
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5110668
• MDR Text Key: 27187280
• Report Number: 2032593-2015-00018
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 34-5110
• Device Lot Number: M019932E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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