MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
Additional Manufacturer Narrative
Visual inspection: the device was inspected.It was observed that the screw shaft was fractured and consistent wear was seen.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Non-union may have contributed to the failure.Per the mesa surgical technique, 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.However, the root cause for the polyaxial screw fracture could not be determined conclusively.
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
Additional Manufacturer Narrative
D.9 was updated to reflect product return.Visual inspection: the device was inspected.It was observed that the screw shaft was fractured and consistent wear was seen.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Non-union may have contributed to the failure.Per the mesa surgical technique, 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.However, the root cause for the polyaxial screw fracture could not be determined conclusively.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9983220
• Report Number: 3004774118-2020-00079
• Device Sequence Number: 3895965
• Product Code: NKB
• UDI-Device Identifier: 10888857136113
• UDI-Public: 10888857136113
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2020

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: 801-06540
• Device Catalogue Number: 801-06540
• Device Lot Number: ETER07J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 08/14/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 08/14/2020; 09/08/2020
• 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