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

Model Number	10-1045
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
X-ray image confirms rod break (l5-s1).Product has not been returned.Multiple attempts have been made to have the product returned for evaluation.No further evaluation of the product can be completed at this time.Labeling notes, warnings and precautions include the following: there are many biological and mechanical factors that affect the longevity of these devices including anatomical stability, patient activity level and patients compliance with post-surgical instructions.These internal fixation devices are load sharing devices that hold bony structures in alignment until healing occurs, if healing is delayed, or does not occur, the implant may eventually disassemble, loosen bend or break.In conclusion, there are no material non-conformances on the part number.Actual device has not been evaluated.Length of implantation and material fatigue may have contributed to the event, but no conclusion can be drawn at this time.The root cause is unknown.
Event or Problem Description
Index procedure was a t10 ilium degen scoli case from (b)(6) 2016.It was discovered during a routine follow up that a rod was broken.On (b)(6) 2019 patient underwent revision surgery for rod breakage at the caudal end of the construct between l5-s1.The revision consisted of cutting the rod, removing a screw and extending the lateral connectors to t4.No patient injury reported with this event.

• Brand Name: UCR FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8916099
• Report Number: 3012120772-2019-00025
• Device Sequence Number: 1812294
• Product Code: NKB
• UDI-Device Identifier: 10889981029432
• UDI-Public: 10889981029432
• Combination Product (Y/N): N
• PMA/510(K) Number: K043232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 10-1045
• Device Catalogue Number: 10-1045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/21/2019
• 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: Required Intervention