MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-05545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa polyaxial screw inner collet fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that a mesa polyaxial screw inner collet fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
D4 was updated from 'zahp 03s' to 'zahp.' visual, functional, material, and dimensional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.No further investigation for this event is possible at this time as no device and insufficient information was received.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10018392
• Report Number: 3004774118-2020-00080
• Device Sequence Number: 2168038
• Product Code: NKB
• UDI-Device Identifier: 10888857135611
• UDI-Public: 10888857135611
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 801-05545
• Device Catalogue Number: 801-05545
• Device Lot Number: ZAHP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR