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

Catalog Number 1101-10001

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); No Information (3190)

Event Date 06/14/2016

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 no lot number has been identified/confirmed in this case.Since the set screw remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.During the revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during the revision.No definitive root cause can be determined.Device remains in patient.

Event Description

It was reported to k2m, inc.On 6/1/2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.

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 no lot number has been identified/confirmed in this case.Since the set screw was not returned, no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.Device remains in patient.

Event Description

It was reported to k2m, inc.On 6/1/2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.Patient had a fall and was revised again on (b)(6) 2016.

• Brand Name: CASPIAN OCT 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 ; 5719192000
• MDR Report Key: 5756195
• MDR Text Key: 48398817
• Report Number: 3004774118-2016-00053
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10888857015593
• UDI-Public: 10888857015593
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 1101-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR