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

Model Number	76-0010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was communicated from a distributer a revision surgery took place to remove three caps that allegedly become dislodged postop.Patients current condition is unknown.No x-rays or radiographs were provided.During the review of the dhr for lot mc99694g, it was concluded that the product was inspected and accepted for use by the quality control department on 08/08/2017 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.During the review of the dhr for lot ma92913f, it was concluded that the product was inspected and accepted for use by the quality control department on 08/01/2016 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.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 locking caps were returned to the manufacturer.At this time, the internal complaint / investigation is open.The root cause is currently unknown.
Event or Problem Description
On (b)(6) 2017, patient underwent spinal deformity scoliosis surgery consisting of posterior pedicle fixation bone screws; levels of fixation are unknown.The initial surgery was completed without complication.First post-operative follow up it was observed the locking caps were disengaged.No radiographs provided for review.Revision surgery was preformed (b)(6) 2018 to replace three locking caps.There was no reported patient injury.Multiple attempts have been made for additional information.

• Brand Name: MALIBU
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7862825
• Report Number: 3012120772-2018-00020
• Device Sequence Number: 11170979
• Product Code: NKB
• UDI-Device Identifier: 10889981079291
• UDI-Public: 10889981079291
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: KO51942
• 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): 08/30/2018

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: Health Professional
• Device Model Number: 76-0010
• Device Catalogue Number: 76-0010
• Device Lot Number: MC99694G & MA92913F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2018
• 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
• Patient Age: 13 YR