MAUDE Adverse Event Report: K2M. INC EVEREST SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number E5112-08570

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 10.30.2018 it was reported to k2m, inc.That a screw broke approximately 7-9 months post-operatively.Patient was revised on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The instrument was returned, visually and functionally inspected.Upon review of the part, it was observed that the head had sheared in a clockwise deformity pattern.The shear face was raised at three intervals that suggest rotational torque forces coalesced at these sites.Review of the x-ray show that the screw was at the distal end of the construct.The amount of overhang from the rod is unclear.Rotational forces coupled with the cantilever forces at the distal end of the construct may have contributed to this specific failure nature.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a screw broke approximately 7-9 months post-operatively.Patient was revised on (b)(6) 2018.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8110173
• MDR Text Key: 128576990
• Report Number: 3004774118-2018-00168
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: E5112-08570
• Device Lot Number: EUEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 12/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention