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

Catalog Number 55-7035

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

This is 2 of 3 reports.Other mtg reports: 2032593-2016-00005 / 2032593-2016-00007.It was reported that in the one year revision, the surgeon noticed in the x-rays that the 2 caudal screws were broken.The original surgery went perfectly and the surgeon followed the surgical technique step by step.The cage remains in its place for the time being.No further information was provided.

Manufacturer Narrative

The alif construct consisted of an anterior plate and four bone screws.There were two lots recorded during the initial surgery.It is unknown which lot (s) fractured.Review of the dhrs (p809106a, aa321018a -documented in 2032593-2016-00007) noted that the products were inspected and accepted for use by the quality control department on 10-29-2008 and 09-02-2008 respectively and met all specified parameters of the receiving inspection report with no material non-conformances or manufacturing errors that may have caused or contributed to this mode of failure.The implants remain in-situ, and no further investigation can be completed at this time.The device has been implanted for 21 months.Review of labeling notes: warning, cautions and precautions: "nonunion or pseudoarthrosis, possibly requiring further surgery." "implants are subject to repeated stresses in use, and their strength is limited by the size and shape of the human spine." "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery" radiographs depicting the fracture, confirmed the event.Patient activity at the time or prior to the event is unknown.The degree of spinal instability at s1-l5 level and the stability of the adjacent segment (l4-l5) motion preservation implantation ( pro_disc) is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.The root cause of this reported event has not been determined.

• Brand Name: ZUMA
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; 2302 la mirada dr.; 2302 la mirada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 2302 la mirada dr.; vista CA 92084
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5394155
• MDR Text Key: 37619411
• Report Number: 2032593-2016-00006
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 55-7035
• Device Lot Number: P809106A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2008
• 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 Age: 40 YR