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	05/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted straight cocr rod is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
During a vcr (vertebral column resection), a cocr rod fractured and broke.The cocr rod was bent with a french bender on the back table with an approximate 90 degree bend over the area of the vcr.Once placing the cocr rod and securing it into the screws, in-situ benders were used to get additional correction through the vcr section when the cocr rod fractured.The surgeon indicated that very little additional force was applied during the in-situ bend.The event caused over a 30 minute delay in the case.
Additional Manufacturer Narrative
Upon review of the rod, wear markings were identified across the fracture line center and it appears that the fracture initiated from the wear markings.The wear markings are a result of surgeon manipulation of the rod with an instrument.An attempt was made to recreate the failure as described by the sales rep using the instruments available in the arsenal set; french bender ((b)(4)), in-situ benders ((b)(4)), and multipurpose forceps ((b)(4)).However, recreation of the wear marks were not present nor did the rod fracture.Therefore, it is unknown what specific use or instrument resulted in the wear marks which directly contribute to the rod fracture.Additionally, the lot history was reviewed.Both the raw material and dimensions were found to be within specification.

• 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: 7574169
• Report Number: 2027467-2018-00033
• Device Sequence Number: 19188655
• Product Code: NKB
• UDI-Device Identifier: 00844856073432
• UDI-Public: (01)00844856073432(10)8701006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: Physician
• Device Model Number: 48007-55-500
• Device Catalogue Number: 48007-55-500
• Device Lot Number: 8701006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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