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

Catalog Number 76-0010

Device Problems Disassembly (1168); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

No films, cts, or radiographs confirming the event were received.Lot numbers could not be verified as the devices were not returned.No further product evaluation could be completed at this time.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 Description

Patient had bilateral posterior construct from t4-l3.The patient had a change to posture suggesting a change in the construct.Follow up appointment determined there was a axial slip on the caudal end at l3.Revision occurred on (b)(6) 2017 to replace the loose lock screws and secure the construct.Index surgery date unknown.

• Brand Name: MALIBU
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SEASPINE INC.; carlsbad CA 92008
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 6869804
• MDR Text Key: 86591898
• Report Number: 3012120772-2017-00011
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981079291
• UDI-Public: 10889981079291
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 76-0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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