MAUDE Adverse Event Report: K2M, INC. CASPIAN SPINAL SYSTEM; SPINAL FIXATION SYSTEM

Catalog Number 1101-03516M

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been 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) 2017, it was reported to k2m inc.That a plate had backed out about six months post-operatively.The patient was revised on (b)(6) 2017.

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.The proximal (tulip head) portion was examined at the fracture face and suggested rapid tension fracture had occurred.Review of the fluoroscopy showed the screw head portion lifted away from the distal screw fracture piece by approximately 6-7mm indicating posterior pull away force was experienced.This suggests that significant reduction force may have been necessary intraoperatively.Overload force or trauma could have contributed to an immediate tension fracture.However, a specific cause for this event could not be confirmed.Further information received indicated that the subject device was the fractured screw instead of the cervical plate that was reported earlier.

Event Description

On (b)(6) 2017, it was reported to k2m inc.That a cervical polyaxial screw fracture had occured.The patient was revised on (b)(6) 2017.

• Brand Name: CASPIAN SPINAL SYSTEM
• Type of Device: 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: 7052317
• MDR Text Key: 92738028
• Report Number: 3004774118-2017-00194
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153370
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 1101-03516M
• Device Lot Number: EAGF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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: 201-90105 LOT EGVC
• Patient Outcome(s): Required Intervention