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

Model Number	91-2109
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the issue is unknown but may be the result of some action by the user or factor of the environment, which can be the consequence or result of possible excessive torsional force, omission of proper surgical technique or improper surgical technique (patient prep, over angulation, or off-center screw placement).The action taken in response to the malfunction does not eliminate the potential of an injury from occurring, such as intra-operative replacement of damaged components in which fragments remain within the surgical site.During the review of the dhr for the lot , found that the product was inspected and accepted for use by the quality control department on 04/29/2014 specific to the product issue.Surgery was completed and no patient injury was reported with the event.
Event or Problem Description
On (b)(6) 2019, a patient underwent spinal surgery consisting of posterior pedicle fixation bone screws.While placing a pedicle bone screw the tip of the screw driver broke off inside the screw.The tip of the driver remains in the screw.Surgery was not delayed, and the case was completed with no patient injury reported.

• Brand Name: MALIBU PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad,
• MDR Report Key: 9252643
• Report Number: 3012120772-2019-00029
• Device Sequence Number: 16644933
• Product Code: NKB
• UDI-Device Identifier: 10889981080563
• UDI-Public: 10889981080563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 91-2109
• Device Lot Number: AL562621G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR