MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 5.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-35540M-SG
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that the outer collet of the tulip "fell down" during locking of a mesa uniplanar screw.There was a surgical delay of approximately 10 minutes while the outer collet was pulled back up and final locked.The surgery was completed successfully with no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Since the device is not available for evaluation, an exact cause of the reported event could not be determined.Per email correspondence with sales rep, the screw was implanted at a difficult angle and the surgeon appeared to apply excess force when the issue occurred.Potential causes include: excess force applied, difficult patient anatomy, damaged screw or lock, etc.
Event or Problem Description
A physician reported that the outer collet of the tulip "fell down" during locking of a mesa uniplanar screw.There was a surgical delay of approximately 10 minutes while the outer collet was pulled back up and final locked.The surgery was completed successfully with no adverse consequence to the patient.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 5.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11439991
• Report Number: 3004774118-2021-00068
• Device Sequence Number: 3497167
• Product Code: NKB
• UDI-Device Identifier: 10888857139886
• UDI-Public: 10888857139886
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 801-35540M-SG
• Device Catalogue Number: 801-35540M-SG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1