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

Catalog Number 2901-10001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.Visual examination of part revealed no obvious signs of cross threading.However, linear marking across the underside surface indicate that the rod was not fully seated within the laminar hooks resulting in non-ideal contact between the rod and the set screws when fully tightened.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which broken laminar hooks, bands and set screw were removed.Revision surgery took place on (b)(6) 2017.Related to 3004774118-2017-00158, 3004774118-2017-00168 and 3004774118-2017-00170.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL FIXATION SYSTEM
• 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: 6984993
• MDR Text Key: 90477309
• Report Number: 3004774118-2017-00169
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

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: 2901-10001
• Device Lot Number: FEFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2016
• 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: 2901-80038 LOT DTYB; 2901-80040 LOT EBNC; 5401-85500 LOT EPAH; 5416-F04730-SG LOT EEKP-22975
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR