MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-06555
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.
Event or Problem Description
It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog and no similar complaints were identified.From the ifu: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.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.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Without the device, a definite cause cannot be determined.Based on the length of implantation, pseudoarthrosis or complete healing are possible causes.Additional possible causes from the ifu include insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions.
Additional Manufacturer Narrative
The device has been received and sections d and h have been updated.The screw was returned in 2 pieces with the tulip disengaged from the screw shank.Markings from being implanted were present on the device.Anodization loss on the collet indicates the screw was fully locked.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed, no adverse trends were identified.From the ifu: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.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 re-fracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Based on the duration of implantation, pseudoarthrosis or complete healing are potential causes; however, a definitive root cause cannot be established with the information available.
Event or Problem Description
It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X55 MM
• 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: 13025338
• Report Number: 3004774118-2021-00403
• Device Sequence Number: 1893782
• Product Code: NKB
• UDI-Device Identifier: 10888857046986
• UDI-Public: 10888857046986
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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: 3001-06555
• Device Catalogue Number: 3001-06555
• Device Lot Number: FUHJ00R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 03/16/2022; 04/07/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 04/07/2022; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown