MAUDE Adverse Event Report: SPINEOLOGY INC. PALISADE PEDICULAR FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Catalog Number	670-4110
Medical Device Problem Codes	Device Slipped (1584); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because both rods disengaged from the spinal construct, spineology is submitting two (2) mdrs; one for each rod.The following mdr numbers represent the rods associated with this event: 2135156-2016-00009, 2135156-2016-00010.Device remains implanted.
Event or Problem Description
Prior to the initial surgical procedure, the patient was positioned on a jackson table.The patient received a multi-level spinal construct with placement of intervertebral body fusion devices on (b)(6) 2016.During placement of the rods, the physician was unable to advance the rods fully beyond the tulip heads due to interference from either soft tissue or bone.Multiple radiographic images of the final construct were taken at different angles and the physician felt comfortable with the purchase/interface of the rods and set screws.Following the surgical procedure, the patient reported hearing a "pop" in his back when he was rolling over in bed.Follow-up radiographic imaging revealed that both rods had slipped from the tulip heads at the caudal end of the construct while the set screws remained in place.The physician intends to perform a second surgical procedure.

• Brand Name: PALISADE PEDICULAR FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; st. paul MN 55128 5455
• MDR Report Key: 6017495
• Report Number: 2135156-2016-00010
• Device Sequence Number: 10783358
• Product Code: NKB
• UDI-Device Identifier: M7406704110
• UDI-Public: M7406704110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2016

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: Physician
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 670-4110
• Device Lot Number: S16138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/11/2016
• 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: Other
• Patient Age: 49 YR
• Patient Weight: 198