MAUDE Adverse Event Report: K2M, INC. SAHARA STABLILIZATION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 5808-21730L15

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 04/13/2017

Event Type  malfunction  

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.In situ.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a surgery took place in which a screw broke during insertion.Surgery took place (b)(6) 2017.

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 interbody remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It was reported that the interbody cage was put in place.A screw was inserted then removed.The surgery was completed absent of any of the three screws.During post op follow up it was observed the implant had migrated anterior approximately 4 mm.Not utilizing the screws potentially contributed to interbody migration.In situ.

Event Description

On 04/15/2017 it was reported to k2m, inc.That a surgery took place in which a screw broke during insertion.Surgery took place (b)(6) 2017.

• Brand Name: SAHARA STABLILIZATION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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 ; 5719195195
• MDR Report Key: 6563463
• MDR Text Key: 75048904
• Report Number: 3004774118-2017-00051
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151481
• 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: 04/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5808-21730L15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2017
• 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