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

Catalog Number	10-1045
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
X-ray image confirms rod break (l2).Product and product manufacturer confirmed through archived sales data from index surgery.No product will be returned, as it remains in the patient.No further evaluation of the product can be completed at this time.Patient has degenerative disc disease & rheumatoid arthritis.It is unknown if the patient complied with post-op care.Patient indicated no fusion in l2.Patient indicated did not sustain a fall/impact of some sort.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 other rod fracture complaints or material non-conformances on the part number which suggest that a manufacturing error may have caused or contributed to this mode of failure.Actual device has not been evaluated.Length of implantation and pseudo arthritis, material fatigue may have contributed to the event, but no conclusion can be drawn at this time.The root cause is unknown.Discarded by hospital.
Event or Problem Description
On (b)(6) 2015 patient underwent revision surgery for rod slippage at the caudal end of the construct.The revision surgery also included a pedicle subtraction osteotomy (pso) to correct flat back and to extend the construct one level to s2.Patient continued treatment for 18 more months.On (b)(6) 2017, patient heard pop sound and a post-operative examination confirmed the rod break at l2.Patient indicated she didn't achieve solid fusion in l2.No corrective action such as revision surgery has occurred.

• 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: 6595973
• Report Number: 3012120772-2017-00007
• Device Sequence Number: 324872
• Product Code: KWP
• 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
• 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?: Yes
• 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: 05/12/2017
• 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