MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 3 LEVEL; SIZE 54 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	208-43F54
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative screw insertion, a pyrenees constrained cervical plate was unable to lock and capture the four pyrenees constrained cervical self-tapping screws.There were no adverse consequences to the patient.The procedure was completed successfully with a 30 minute delay to surgery by using an alternatively available plate and screws.
Additional Manufacturer Narrative
Visual inspection: no abnormalities were observed with the returned screws.Upon visual inspection of the returned plate, heavy scratching on the surface area of the plate was noted.It was observed that the plate experienced deformation around the screw holes.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was communicated that the last screw at the distal end of the plate kept spinning and failed to lock.Three different diameter screws were attempted to be placed in the same screw hole; however, none were able to lock.Correspondence with rep indicates that the plate was not bent, and the screws were not realigned multiple times.Due to the damage on the screw holes, functional testing of the locking mechanism could not be conducted conclusively.As the plate was returned damaged, and certain angulation/forces experienced in an intra-operative environment could not be replicated during functional testing, the failure mode and cause could not be determined conclusively.
Event or Problem Description
It was reported that during intra-operative screw insertion, a pyrenees constrained cervical plate was unable to lock and capture the four pyrenees constrained cervical self-tapping screws.There were no adverse consequences to the patient.The procedure was completed successfully with a 30 minute delay to surgery by using an alternatively available plate and screws.

• Brand Name: CONSTRAINED PLATE, 3 LEVEL; SIZE 54 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11575156
• Report Number: 3004774118-2021-00088
• Device Sequence Number: 11875869
• Product Code: KWQ
• UDI-Device Identifier: 10888857031159
• UDI-Public: 10888857031159
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 208-43F54
• Device Catalogue Number: 208-43F54
• Device Lot Number: DLYN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR