MAUDE Adverse Event Report: K2M, INC. PARALLEL ROD CONNECTOR, CLOSED/CLOSED, NARROW; SIZE 4.5MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-84545N
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled revision surgery to extend the construct, the mesa parallel rod connector was observed to be "loose." the device was removed and replaced with another connector.Upon explantation, the "nuts" were found to be "deformed." no adverse consequences to the patient were reported.
Event or Problem Description
It was reported that during a scheduled revision surgery to extend the construct, the mesa parallel rod connector was observed to be "loose." the device was removed and replaced with another connector.Upon explantation, the "nuts" were found to be "deformed." no adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The device was not routed to post market surveillance and was therefore unavailable for evaluation.It is suggested that the set screws may have been subjected to torsional overload.A torque limiting handle is included in the set to prevent torsional overload during final tightening.However, as the device was not available, we were unable to determine the precise circumstances of the failure.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.H3 other text : device was not returned.

• Brand Name: PARALLEL ROD CONNECTOR, CLOSED/CLOSED, NARROW; SIZE 4.5MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11207555
• Report Number: 3004774118-2021-00016
• Device Sequence Number: 11951975
• Product Code: NKB
• UDI-Device Identifier: 10888857052437
• UDI-Public: 10888857052437
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 3001-84545N
• Device Catalogue Number: 3001-84545N
• Device Lot Number: JWTH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1