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

Catalog Number 5101-90159

Device Problems Separation Failure (2547); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/12/2018

Event Type  malfunction  

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 (b)(6) 2018 it was reported to k2m, inc.That a rod inserter bearing drive did not function as intended intra-operatively resulting in a significant surgical delay.Surgery took place on (b)(6) 2018.

Event Description

On 07.12.2018 it was reported to k2m, inc.That a rod inserter did not function as intended intra-operatively as a result, there was a significant delay in surgery.

Manufacturer Narrative

The subject was not returned, however, a thorough investigation was completed as the lot number has been identified/confirmed in this case.Since the rod inserter bearing drive was not returned, no physical, chemical evaluation could be performed, and a root cause of the reported issue could not be ascertained.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va VA 20175
• MDR Report Key: 7769624
• MDR Text Key: 116645253
• Report Number: 3004774118-2018-00117
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5101-90159
• Device Lot Number: GGFR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other