MAUDE Adverse Event Report: K2M, INC. DENALI SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 101-555500

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product has not been returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.If more information becomes available, manufacturer will file a follow-up report at that time.

Event Description

It was reported to k2m, inc on (b)(6) 2015 that a revision surgery is needed in which a fractured rod needs to be removed.The patient reportedly had a fractured rod approximately 3 years post-op.Revision surgery has taken place but date has not been confirmed.

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 rod was not returned no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A review of the manufacturing and inspection records did not reveal any contributing information/trends.

• Brand Name: DENALI SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 751 miller dr se; suite f-1; leesburg, VA 20175 ; 5719192000
• MDR Report Key: 5338474
• MDR Text Key: 34790196
• Report Number: 3004774118-2015-00062
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857006270
• UDI-Public: 10888857006270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101-555500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• 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