MAUDE Adverse Event Report: SPINECRAFT APEX SPINE SYSTEM; COCR ROD

Catalog Number	6000-CR600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation was initiated for the complaint product.A review of the dhr and other records was conducted for the complaint product.The records showed that the complaint product was designed and produced according to the specified material and manufacturing & production processes.Distribution records were also reviewed.All items in this lot were stored and distributed in accordance with the company's approved procedures.A total of (b)(4) items in this lot were received in may of 2012 and a total of (b)(4) have been used in surgeries since that date without any problem.Should the product become available, a physical evaluation will be conducted.If the results of the complaint investigation identify a corrective action or additional relevant information, then a supplemental report will be filed with the results.
Event or Problem Description
Surgeon performed the first stage of a multi-staged posterior surgery on (b)(6) 2016 to treat a patient with adult scoliosis.The patient underwent the second surgery on (b)(6) 2016 to complete the treatment.Four (4) months later the patient felt a pop and x-rays revealed a rod fracture on the right side at l5/s1.She now has pain.Patient is scheduled for a revision surgery.
Additional Manufacturer Narrative
A portion of the subject product was finally returned and was visually inspected.Inspection showed that the rod broke close to notch created during rod bending with a french rod bender.The product was analyzed for structural and material inconsistencies; fracture may be due to bending fatigue.Less extreme bending of the rod is advised.There has been no issue identified in the manufacturing or release of the subject product that could have contributed to the reported problem and no systemic trends requiring immediate action have been observed.We will monitor any emerging trends.

• Brand Name: APEX SPINE SYSTEM
• Common Device Name: COCR ROD
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont 60559 5511
• MDR Report Key: 5852259
• Report Number: 3004717358-2016-00002
• Device Sequence Number: 1457048
• Product Code: NKB
• UDI-Device Identifier: M8246000CR6001
• UDI-Public: M8246000CR6001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2016

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: No Information
• Device Catalogue Number: 6000-CR600
• Device Lot Number: 62170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 10/21/2016
• 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: Required Intervention
• Patient Age: 59 YR