MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM; LOCKING CAP

Model Number	12-0010
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	Serious Injury
Additional Manufacturer Narrative
The index surgery date is unknown; the revision surgery occurred approximately 3 months postoperatively.The separation was discovered during a routine follow-up via x-ray.Explants have been made available for analysis and the investigation is ongoing.The conclusion is not yet available.Possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
Seaspine was informed on (b)(6) 2020 that a patient who previously underwent spinal surgery from level t2-l2 consisting of seaspine's malibu spinal system required revision surgery as a result of a postoperative locking cap separation at the t12, l1, and l2 levels.
Additional Manufacturer Narrative
The index surgery date is unknown; the revision surgery occurred approximately 3 months postoperatively.The separation was discovered during a routine follow-up via x-ray.Explants were returned to seaspine and examined by engineering.The implants were measured and visually inspected.All critical mating features were found to be within specification with the exception of a feature on the cap component of the 12-0010 locking cap.Damage to the lead-in thread of the set screw component was observed, which is indicative of cross-threading.Cross-threading and misalignment of the set screw component relative to the cap component could have applied excessive force on the lid component during the locking cap insertion process.Patient anatomy could have also contributed to misalignment during the insertion process resulting in cross-threading.Possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

• Brand Name: MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
• Common Device Name: LOCKING CAP
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 11098479
• Report Number: 3012120772-2020-00093
• Device Sequence Number: 17128671
• Product Code: NKB
• UDI-Device Identifier: 10889981000738
• UDI-Public: 10889981000738
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 12-0010
• Device Catalogue Number: 12-0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/14/2021
• 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