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

Model Number 12-0010

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 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
• Type of Device: LOCKING CAP
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10190233
• MDR Text Key: 196271853
• Report Number: 3012120772-2020-00045
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981000738
• UDI-Public: 10889981000738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12-0010
• Device Catalogue Number: 12-0010
• Device Lot Number: MH00762K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention