MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-06545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised for a denali screw, that fractured at the head of the tulip at the l5/s1 level, and a disc compression.The patient noted pain from the disc compression, not from the screw fracture.The patient fused and was reported to be doing "heavy manual labor." a new screw was placed in parallel at left side of s1.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the screw was fractured below the second thread.The distal part of the screw remains in the patient and was therefore not available for evaluation.Device and complaint history were reviewed and no relevant manufacturing issues or similar complaints were identified.As the screw was implanted 8 years ago, the most likely cause of the broken screw was determined to be material fatigue.Per the surgical technique, metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual (patient performs heavy manual labor).
Event or Problem Description
The patient was revised for a denali screw, that fractured at the head of the tulip at the l5/s1 level, and a disc compression.The patient noted pain from the disc compression, not from the screw fracture.The patient fused and was reported to be doing "heavy manual labor." a new screw was placed in parallel at left side of s1.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10307940
• Report Number: 3004774118-2020-00148
• Device Sequence Number: 14306953
• Product Code: NKB
• UDI-Device Identifier: 10888857002777
• UDI-Public: 10888857002777
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 101-06545
• Device Catalogue Number: 101-06545
• Device Lot Number: AVRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 06/28/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/23/2020
• 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: 54 YR
• Patient Weight: 118