MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 8.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-08545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was observed via x-ray that an everest polyaxial screw, in the left s1, broke post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the fracture occurred approximately halfway down the screw shank.The fracture face was uneven and raised on one side.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per the ifu, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.Non-union may have contributed to the failure.According to the rep, fusion was not achieved at the event site.
Event or Problem Description
It was observed via x-ray that an everest polyaxial screw, in the left s1, broke post-operatively.Revision surgery has occurred.

• Brand Name: POLYAXIAL SCREW; SIZE 8.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11515443
• Report Number: 3004774118-2021-00080
• Device Sequence Number: 11784143
• Product Code: NKB
• UDI-Device Identifier: 10888857043053
• UDI-Public: 10888857043053
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2911-08545
• Device Catalogue Number: 2911-08545
• Device Lot Number: CKEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: 43 YR