MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Visual inspection: it was observed that the screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Excessive torsional forces during insertion may have overloaded the structural integrity of the screw, resulting in a failure of this nature.
Event or Problem Description
This report summarizes 1 malfunction event where a yukon oct polyaxial screw broke upon insertion into the t1 pedicle intra-operatively.Surgery was successfully completed with another screw and a five minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10764756
• Report Number: 3004774118-2020-00292
• Device Sequence Number: 3840917
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: JTXU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1