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

Catalog Number	3601-13514
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/07/2015
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 no lot number has been identified/confirmed in this case.Since the screw remains in the patient no physical, material, chemical evaluation could be performed.If more information becomes available manufacturer will file a follow-up report at that time.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2015 that a surgery took place on (b)(6) 2015 in which a titanium offset screw was unable to be final tightened and was left in the patient.Revision surgery is not planned.
Additional Manufacturer Narrative
The physician was able to use the torque handle to lock the remaining two screws without any issues.The screw could not be removed, therefore, the patient's bone was most likely stripped, which may have contributed to the inability to lock the screw initially.The patient is reportedly doing well.

• Brand Name: CHESAPEAKE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• MDR Report Key: 5358469
• Report Number: 3004774118-2015-00071
• Device Sequence Number: 13466708
• Product Code: OVE
• UDI-Device Identifier: 10888857081093
• UDI-Public: 10888857081093
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/11/2015

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: 3601-13514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2016
• Supplement Report FDA Received Date: 02/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR