MAUDE Adverse Event Report: ALPHATEC SPINE INC COCR STRAIGHT ROD, 5.5 MM X 500 MM (CO-28CR-6MO); PEDICLE SCREW SYSTEM

Model Number	48007-55-500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been returned for evaluation.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
Both rods had been implanted and the final set screw on the proximal left side t4 inserted.The surgeon noticed that additional sagittal correction was required.While adding more kyphosis, the rod snapped and broke around the c5.The rod and detached fragments were completely removed from the patient.
Additional Manufacturer Narrative
The returned implant is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released in accordance with the device master record.The material for this rod is cobalt chrome (co-28cr-6mo) alloy 2 per as-m-0026.This cobalt chrome is a high carbon alloy which may lead to a higher likelihood of fracture compared to different cobalt chrome alloys (such as pn 480027-55-xxx cobalt chrome alloy 1 per as-m-0054).In addition, the rod fracture was found to be located at a notch resulting from in-situ bending.The notch presents an increased stress concentration that may lead to crack initiation and result in rod fracture.

• Brand Name: COCR STRAIGHT ROD, 5.5 MM X 500 MM (CO-28CR-6MO)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8727765
• Report Number: 2027467-2019-00032
• Device Sequence Number: 11406210
• Product Code: NKB
• UDI-Device Identifier: 00844856073432
• UDI-Public: (01)00844856073432(10)CT89908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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: 48007-55-500
• Device Catalogue Number: 48007-55-500
• Device Lot Number: CT89908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 06/06/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/06/2019; 09/11/2019
• 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: Other
• Patient Age: 17 YR