MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-05535
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the third of three screws.
Event or Problem Description
It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the third of three screws.
Additional Manufacturer Narrative
Visual inspection: the returned screw was not fractured; however, the inner collet had deformations around its tab.Scratching can be seen around the outer collet.Functional inspection: the screw was functionally inspected and the inner and outer collet were able to partially/final lock using corresponding instrumentation.No abnormalities were found.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Upon inspection of the returned device, the alleged failure mode could not be confirmed as the device was not fractured.The inner collet had loss of anodization around its tab which could have resulted from difficulty attaching/detaching the reduction instrument during the procedure.The observed loss of anodization does not impact functionality of the device.The screw was able to attach to a reduction instrument and was also able to partially/final lock with a locker.No device issues were found.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10353172
• Report Number: 3004774118-2020-00162
• Device Sequence Number: 11370622
• Product Code: NKB
• UDI-Device Identifier: 10888857046733
• UDI-Public: 10888857046733
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 10/23/2020

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: 3001-05535
• Device Catalogue Number: 3001-05535
• Device Lot Number: EJDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1