MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mesa polyaxial screw in s1 migrated post-operatively.While repositioning a screw at l5, the surgeon noticed that the corresponding rod was completely loose from the screw that was implanted in s1.The rod was only being held by the screw at l5.The s1 screw was removed and replaced with a new screw.This report represents the s1 screw.
Event or Problem Description
It was reported that a mesa polyaxial screw in s1 migrated post-operatively.While repositioning a screw at l5, the surgeon noticed that the corresponding rod was completely loose from the screw that was implanted in s1.The rod was only being held by the screw at l5.The s1 screw was removed and replaced with a new screw.This report represents the s1 screw.
Additional Manufacturer Narrative
Visual, functional, material, and dimensional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.We were unable to confirm the failure mode as no devices or radiographic images were available for evaluation.It is possible that the screw at s1 was not fully locked.Post-operative patient activities may have introduced unanticipated loading to the construct, overloading the capture strength of the screw at s1.There is also a possibility that the screw at s1 was never locked during the index surgery.However, as no devices or radiographic images were available for evaluation, the root cause could not be determined conclusively.Device not returned.
Additional Manufacturer Narrative
The screw was returned and inspected and noted to be positioned in the unlocked state.The screw did not present any loss of anodization and was able to be locked and unlocked as intended.Device history records were reviewed and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.The mesa deformity surgical technique was reviewed and the following relevant information was identified: adequately instruct the patient.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.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.The screw did not present any loss of anodization, suggesting that the screw may have not been fully locked during the index surgery.It is also possible that post-operative patient activities introduced unanticipated loading to the construct, resulting in rod disengagement.
Event or Problem Description
It was reported that a mesa polyaxial screw in s1 migrated post-operatively.While repositioning a screw at l5, the surgeon noticed that the corresponding rod was completely loose from the screw that was implanted in s1.The rod was only being held by the screw at l5.The s1 screw was removed and replaced with a new screw.This report represents the s1 screw.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10121092
• Report Number: 3004774118-2020-00104
• Device Sequence Number: 14361689
• Product Code: NKB
• UDI-Device Identifier: 10888857136113
• UDI-Public: 10888857136113
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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: 801-06540
• Device Catalogue Number: 801-06540
• Device Lot Number: JERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 03/31/2021
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 10/26/2020; 04/28/2021
• 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