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

Catalog Number M5111-06545

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/11/2018

Event Type  malfunction  

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) 2018 it was reported to k2m, inc.That a broken polyaxial screw was discovered during a planned revision surgery.

Event Description

On 07.13.2018 it was reported to k2m, inc.That a broken polyaxial screw fractured during a planned revision surgery and the shaft remains in the patient.Surgery took place (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to the manufacturer for evaluation, and a thorough investigation was complete was completed, as the lot number has been identified/confirmed in this case.Since a portion of the screw remains in the patient and the other portion was retained by the hospital, no physical, chemical evaluation could be performed, and the root cause od the reported issue could not be ascertained.

• Brand Name: EVEREST MI SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 7764264
• MDR Text Key: 116559761
• Report Number: 3004774118-2018-00122
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K132361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M5111-06545
• Device Lot Number: EHFP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1