MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD, BULLETED HEX; SIZE Ø5.5X175 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	1001-A55175
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a denali mi straight rod 'broke' post-operatively.Revision has occurred and the rod has been replaced.
Additional Manufacturer Narrative
The explanted device was returned for evaluation.The fracture surface shows fine beach marks indicating fatigue failure.Material deformation and marks of an unknown origin were identified on the rod.It is possible that the deformation and/or marks occurred at implantation during final tightening, compression, or distraction or that power tools were used during rod explanation.Manufacturing records were not reviewed as the lot number is unknown.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.From the denali surgical technique: metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing it can actually increase the risk of refracture in an active individual.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.Based on the available information, it is likely that the rod fracture occurred due to fatigue.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
Event or Problem Description
It was reported that a denali mi straight rod 'broke' post-operatively.Revision has occurred and the rod has been replaced.

• Brand Name: STRAIGHT ROD, BULLETED HEX; SIZE Ø5.5X175 MM, TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13156875
• Report Number: 3004774118-2022-00001
• Device Sequence Number: 20242117
• Product Code: NKB
• UDI-Device Identifier: 10888857001497
• UDI-Public: 10888857001497
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1001-A55175
• Device Catalogue Number: 1001-A55175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG