MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM; POLYAXIAL SCREW DRIVER SHAFT

Model Number 91-2111

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The remaining shaft of the instrument has not been provided for evaluation.Additionally, no radiographs have been provided for analysis.While the reported complaint cannot be confirmed or properly evaluated at this time, given the age of the device (approximately 10 years), the failure reported is consistent with normal age and wear.Review of labeling: warnings and precautions: seaspine instruments should only be used with seaspine implants.Do not attempt to use with other competitive devices.Avoid application of excessive stress on surgical instrumentation.Carefully read and follow any package insert which accompanies the implants to be used with this instrumentation.Instruments must be cleaned and decontaminated before they are returned to the manufacturer for any reason.Carefully inspect all instruments prior to use.Do not use an instrument that is severely marred or worn, or a cutting instrument with dull edges.Note that at some time, instruments may wear out and should be replaced.

Event Description

On (b)(6) 2020, the patient underwent spinal surgery consisting of seaspine's malibu pedicle screw system.Seaspine was informed on 30 oct 2020 that the implant screwdriver broke while implanting a screw.The driver tip was left in the screw in-situ.No injury was reported, nor any additional medical or surgical treatment.

• Brand Name: MALIBU SPINAL SYSTEM
• Type of Device: POLYAXIAL SCREW DRIVER SHAFT
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 10909207
• MDR Text Key: 243792974
• Report Number: 3012120772-2020-00092
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981080587
• UDI-Public: 10889981080587
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91-2111
• Device Catalogue Number: 91-2111
• Device Lot Number: MW06706B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1