MAUDE Adverse Event Report: SEASPINE INC. UCR FIXATION SYSTEM; SPINAL PEDICLE FIXATION FOR DEGENERATIVE DISC DISEASE

Catalog Number	10-1045
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No part number and/or lot number were reported.Possible part number identified through sales data.No product will be returned, as it was discarded by the hospital.No radiographs, mris or medical records have been received.No further evaluation of the product can be completed at this time.It is unknown if patient's prior degenerative disc disease or rheumatoid arthritis contributed to the instability of the segment.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 patient's 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 other complaints of rod slippage or material non-conformances on the part number which suggest that a manufacturing error may have caused or contributed to this mode of failure.It is unknown if the patient's condition caused or contributed to the alleged rod slip.The root cause is unknown.Discarded by hospital.
Event or Problem Description
On (b)(6) 2015 patient received index surgery (eight level construct t10-s1) to address adjacent segment disease.In (b)(6) 2015 the construct was noted to have a rod slippage at the caudal end of the construct.Revision surgery was performed on (b)(6) 2015 involving a pedicle subtraction osteotomy (pso) to correct flat back and to extend the construct to s2.Patient continued treatment for 18 more months.

• Brand Name: UCR FIXATION SYSTEM
• Common Device Name: SPINAL PEDICLE FIXATION FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6595933
• Report Number: 3012120772-2017-00006
• Device Sequence Number: 16270264
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: Physician
• Device Catalogue Number: 10-1045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/26/2017
• 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
• Patient Age: 58 YR