MAUDE Adverse Event Report: K2M, INC. CHESAPEAKE SPINAL SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	2001-15530
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional 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 screw 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 surgeon believed had driven the screw through the titanium insert of the cage at the time of implantation.Therefore, the screw may not have been locked to the plate allowing it to back out after a few months.Since there is no torque limiting device in the provisional handle/driver, this incident likely occurred during provisional tightening.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a screw back-out.The patient reportedly had a screw back-out approximately 4 months post-op.There are no plans to revise at this time.The patient is asymptomatic.

• Brand Name: CHESAPEAKE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6530268
• Report Number: 3004774118-2017-00042
• Device Sequence Number: 734199
• Product Code: MAX
• UDI-Device Identifier: 10888857025424
• UDI-Public: 10888857025424
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K092211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 2001-15530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1