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

Catalog Number	12-0010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.Returned devices were evaluated and measured.The devices showed no signs of damage and met specifications.It was reported that the patient had already began physical therapy.There was no report that the patient sustained an impact/trauma of any sort.It is unknown if the patient complied with post-op care instructions during this five month period.The degree of spinal instability is unknown.Review of labeling notes: "intraoperative warnings if the 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 to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.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.Postoperative fracture due to trauma, defects or poor bone stock." the root cause of this event cannot be determined.No conclusions can be drawn.
Event or Problem Description
Deformity correction surgery was performed on a adolescent female (age unknown) with posterior fixation from l4- t11 on (b)(6) 2017.Fixation was skipped at levels: left l3, right l1, and both right and left t12.During a routine follow up on (b)(6) 2018 radiograph noted right l4, l3, l2 had loose lock screws.Patient was asymptomatic.Revision surgery was performed replacing two bone screws, and three lock screws.

• Brand Name: MALIBU PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7345444
• Report Number: 3012120772-2018-00005
• Device Sequence Number: 16152733
• Product Code: NKB
• UDI-Device Identifier: 10889981000738
• UDI-Public: 10889981000738
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 12-0010
• Device Lot Number: MD03333K, MC40182K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1