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

Catalog Number 5101-90159

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 04/26/2018

Event Type  Injury  

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 could not be completed as the lot number has not been identified/confirmed in this case.Since the subject device was disposed, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Further investigation revealed that difficulty using the rod inserter might have also caused or contributed in surgical delay.

Event Description

On 5.7.2018 it was reported to k2m, inc.That there was a significant delay in surgery due to intra-op extended tab breakage and difficulty using an instrument.Surgery took place (b)(6) 2018.(related to 3004774118-2018-00077 and 3004774118-2018-00078).

• 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: 7641143
• MDR Text Key: 112434333
• Report Number: 3004774118-2018-00096
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5101-90159
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 5101-90218; 5101-90219; E5112-06545; E5112-07550
• Patient Outcome(s): Other