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

Model Number	12-0019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
X-rays confirming the event were received.Returned device was evaluated by engineering.Evaluation: the point loading of the locking cap onto the rod in conjunction with micromotion post-op may have contributed to the locking cap set screw unthreading.Damage to the lead-in thread of the set screw is indicative of potential cross-threading.Damage to the rod channel of the locking cap is indicative of the locking cap point loading onto one side of the rod.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.
Event or Problem Description
On (b)(6) 2019 a deformity correction surgery was performed.Levels and patient info (age, sex, race) are unknown.A routine follow-up x-ray showed a locking cap had backed out.On (b)(6) 2019 a revision surgery was performed, which consisted of replacing and securing one locking cap.Follow-up to revision determined patient is without pain and recovering well.Surgeon to monitor patient progress through routine follow-ups.

• 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: 8724867
• Report Number: 3012120772-2019-00017
• Device Sequence Number: 13905200
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: 12-0019
• Device Lot Number: MF63006K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention