MAUDE Adverse Event Report: SEASPINE INC. MALIBU; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	76-0100
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.Dhr review cannot be completed as the product has not been returned because the device remains implanted.Multiple attempts have been made to gain additional information.Patient activity at the time or prior to the event is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of labeling notes: warning cautions and precautions, "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery." the root cause of this reported event has not been determined.
Event or Problem Description
Patient's initial posterior lumbar fixation surgery reportedly occurred approximately 3 months ago (exact date unknown.) during follow up visit it was discovered that the both s1 iliac locking screws had loosened, and the rod disassociated from the iliac bone screws.Length of construct and levels treated are unknown.Patient history is unknown.Patient status is unknown.Surgeon is monitoring and is planning a revision surgery, date is unknown.

• Brand Name: MALIBU
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SEASPINE INC.; carlsbad CA 92008
• MDR Report Key: 5848866
• Report Number: 2032593-2016-00012
• Device Sequence Number: 598518
• Product Code: NKB
• UDI-Device Identifier: 10889981079291
• UDI-Public: 10889981079291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 76-0100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1