MAUDE Adverse Event Report: SEASPINE INC. SKIPJACK EXPANDABLE SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	98-3003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review could not be performed as the lot number was not provided and the driver is not available for return, as it was discarded.Additionally, photos of the damaged instrument were not provided.The reported allegation of broken driver tip left in-situ cannot be confirmed at this time.A root cause could not be determined due to lack of physical inspection and device history review.No further information is available at this time.
Event or Problem Description
On (b)(6) 2020 the patient underwent a tlif procedure using the skipjack expandable system.It was reported to seaspine that during the procedure the height expansion driver broke intraoperatively, and the tip remained within the implant in-situ.There was no indication of patient injury.No additional event information is available.

• Brand Name: SKIPJACK EXPANDABLE SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SEASPINE INC.; 5770 armada dr; carlsbad, ca
• MDR Report Key: 10130615
• Report Number: 3012120772-2020-00040
• Device Sequence Number: 16667600
• Product Code: MAX
• UDI-Device Identifier: 10889981138844
• UDI-Public: 10889981138844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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 Catalogue Number: 98-3003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1