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

Model Number	12-0010
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 12-0010 locking cap lot mh00762k and 75-6545 cannulated uni-planar screw lot p256641a were returned for investigation.The implants were inspected and the critical mating features were measured.All critical features were found to be within specification according to the quality inspection report.Visible damage to the lead-in thread of the set screw was observed and is indicative of cross-threading.The cross-threading of the set screw component (12-0010-10) relative to the cap component (12-0010-20) suggests misalignment and stress applied to the lid component (12-0010-30) upon insertion.Based on the review of the implants and the information available, the root cause of the reported fault is surgical technique and cross-threading of the locking cap upon insertion.
Event or Problem Description
Seaspine was informed on (b)(6) 2020 that a patient who previously underwent spinal surgery consisting of seaspine's malibu spinal system required revision surgery as a result of a postoperative locking cap separation at l5.The index surgery and date of revision is unknown.The separation was discovered during a routine follow-up via x-ray.

• 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
• MDR Report Key: 10190233
• Report Number: 3012120772-2020-00045
• Device Sequence Number: 19059562
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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
• Device Lot Number: MH00762K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/24/2020
• 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