MAUDE Adverse Event Report: SEASPINE SIERRA; SIERRA OCCIPITAL PLATE IMPLANT

Model Number	51-3514
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a sierra cervical construct was removed the same day as initial surgery.No product lot information, explants, radiographs or ct scans have been received.Dhr review and product investigation cannot be completed, as the product was discarded by the hospital.Revision surgery was completed with no additional complications.Surgeon will continue to monitor patient's postoperative progress.Review of labeling notes: intraoperative warnings: if the construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.*contraindications relative contraindications: unsuitable or insufficient bone support.The root cause is unknown, but the patient's anatomical condition and bone quality may have caused or contributed to the event.
Event or Problem Description
During initial surgery, hardware was unable to secure into patient's bone enabling construct to fail.Bone screws, from c3 through c7, backed out allowing rods to slip out of alignment.Revision occurred to remove construct and reportedly re-instrumented two days later.

• Brand Name: SIERRA
• Common Device Name: SIERRA OCCIPITAL PLATE IMPLANT
• Manufacturer (Section D): SEASPINE; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7362869
• Report Number: 3012120772-2018-00007
• Device Sequence Number: 11014706
• Product Code: HRS
• UDI-Device Identifier: 10889981043537
• UDI-Public: 10889981043537
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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 Model Number: 51-3514
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR