MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM; LOCKING CAP, 8.0

Model Number	12-0020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No index surgery or revision information was provided.Additionally, the distributor did not provide the number of patients affected.No implants were made available for review.The root cause cannot be determined at this time.Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Pain, discomfort, or abnormal sensations due to the presence of the device.
Event or Problem Description
On (b)(6) 2020, seaspine was made aware that several patients were experiencing loss of reduction/correction and pain as a result of the disassociation of a malibu spinal system locking cap.

• Brand Name: MALIBU SPINAL SYSTEM
• Common Device Name: LOCKING CAP, 8.0
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 10580974
• Report Number: 3012120772-2020-00075
• Device Sequence Number: 1166171
• Product Code: NKB
• UDI-Device Identifier: 10889981000745
• UDI-Public: 10889981000745
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: Health Professional
• Device Model Number: 12-0020
• Device Catalogue Number: 12-0020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1