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

Catalog Number E5112-07545

Device Problems Break (1069); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 04/19/2018

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) 2018 it was reported to k2m, inc.That a surgery took place in which the extended tabs did not function as intended during implantation which led to a significant delay in surgery.Surgery took place (b)(6) 2018.(related to 3004774118-2018-00058).

Manufacturer Narrative

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

Event Description

On (b)(4) 2018 it was reported to k2m, inc.That a surgery took place in which the extended tabs broke intra-operatively causing a significant delay in surgery.Surgery took place (b)(6) 2018.(related to 3004774118-2018-00058).

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192195
• MDR Report Key: 7510067
• MDR Text Key: 108093972
• Report Number: 3004774118-2018-00069
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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: Physician
• Device Catalogue Number: E5112-07545
• Device Lot Number: FKAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: E5112-07550 LOT UNKNOWN
• Patient Outcome(s): Other