MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-37545M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw, and an unknown delay.No adverse consequences, or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the returned screw had loss of anodization and slight deformation around the inner and outer collet which did not impact the functionality of the device.Functional inspection: the complaint screw was functionally inspected using the returned denali rod as well as a sample rod.The device was able to final lock onto the rods, using a sample quick locker, without issue.The rods were not able to slide along the collets, as reported.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is possible that the screw was not in a completely locked state during the procedure, causing the rod to slip along the screw head.As certain maneuvers applied during the procedure could not be replicated during functional testing, the failure mode could not be confirmed and the root cause could not be determined conclusively.
Event or Problem Description
It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw and an unknown delay.No adverse consequences or medical intervention were reported.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 7.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10824423
• Report Number: 3004774118-2020-00300
• Device Sequence Number: 11682496
• Product Code: NKB
• UDI-Device Identifier: 10888857140660
• UDI-Public: 10888857140660
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 801-37545M
• Device Catalogue Number: 801-37545M
• Device Lot Number: GXXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1