MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD, BULLETED HEX; SIZE 5.5X175 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	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery to replace a broken denali straight rod with bulleted hex.
Event or Problem Description
A patient underwent revision surgery to replace a broken denali straight rod with bulleted hex.
Additional Manufacturer Narrative
Updated information provided in d9 and h3.Corrected information provided in d4.
Event or Problem Description
A patient underwent revision surgery to replace a broken denali straight rod with bulleted hex.
Additional Manufacturer Narrative
Complaint history was reviewed for this lot and no similar complaints were identified.Manufacturing records were reviewed for the corresponding lot number and no relevant issues were identified.The explanted device was returned.It was observed that the rod was fractured into four parts and beach marks were observed on the fracture surface which suggests fatigue fracture.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." correspondence with field representative states that the patient had fused and the patient had normal activity levels.As the rod was implanted in the patient for approximately 20 months and the patient had fused, it is likely that the fracture occurred due to fatigue.

• Brand Name: STRAIGHT ROD, BULLETED HEX; SIZE 5.5X175 MM, TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11655627
• Report Number: 3004774118-2021-00110
• Device Sequence Number: 4224604
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2021

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
• Device Lot Number: HGJC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 07/30/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/25/2021; 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR