MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION MESA SPINAL SYSTEM; ORTHOSIS SPINAL PEDICLE FIXATION

Catalog Number 6201-07545

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That screws backed out, loosened or disengaged approximately 4-6 months post-operatively.The patient was revised on (b)(6) 2019.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review, it was observed that one screw was in the locked position, while the other was in the unlocked position.Signs of corrosion were visible on the inner collet of both screws, and the head assembly of each screw was fixed in place and unable to rotate.It was reported that the patient fell off a horse.Mri and ct scans revealed that the patient had a vertebral body fracture, with prominent implants and bilateral pedicle screw pop-outs.It is likely impact from the trauma caused the vertebral body to fracture as well as caused the pedicle screws to disengage from the rods.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That screws backed out, loosened disengaged approximately 4-6 months post-operatively.The patient was revised on (b)(6) 2019.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That screws backed out, loosened or disengaged approximately 4-6 months post-operatively.The patient was revised on (b)(6) 2019.

• Brand Name: MESA SPINAL SYSTEM
• Type of Device: ORTHOSIS SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8462675
• MDR Text Key: 140274272
• Report Number: 3004774118-2019-00030
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6201-07545
• Device Lot Number: EKHR
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention