MAUDE Adverse Event Report: SEASPINE INC. MALIBU PEDICLE FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	12-6545
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged screw failure cannot be confirmed.The product was not returned for analysis, as it remains implanted.Review of labeling notes: intra-operative warnings: if the system/construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.Postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activity.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.The patient should be advised that implants may bend, break or loosen despite restriction in activity.The root cause is unknown, as additional information is unavailable.No conclusion can be drawn at this time.
Event or Problem Description
On (b)(6) 2019 a patient contacted the manufacturer alleging a post-operative screw failure with a posterior fixation system.Information provided from the patient determined the index surgery date ((b)(6) 2010) and model number (12-6545 malibu polyaxial screw).It is unknown how the screw failure was discovered.It is unknown if a revision is scheduled.No radiographs or case sheet is available.Patient was advised to contact a physician.

• Brand Name: MALIBU PEDICLE FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 9014504
• Report Number: 3012120772-2019-00026
• Device Sequence Number: 2164874
• Product Code: NKB
• UDI-Device Identifier: 10889981001155
• UDI-Public: 10889981001155
• Combination Product (Y/N): N
• PMA/510(K) Number: K051942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 12-6545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1