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

Catalog Number	76-0010
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional 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.Multiple attempts to gain further information made with no response.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
During routine follow up of a spinal derotation and fusion, patient was noted to have an axial slip on a posterior construct.Locking cap was loose on the rod.Revision surgery is planned, but has not occurred.Patient status is unknown.Index 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: 7153464
• Report Number: 3012120772-2017-00017
• Device Sequence Number: 933275
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 76-0010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1