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

Catalog Number	3601-13514
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The investigation is still in process and a follow-up report will be provided at the time of completion.User discarded.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a surgery took place in which two screws were unable to be implanted.The surgery took place (b)(6) 2016.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.During a case with the chesapeake® cervical-ti stabilization system, the surgeon was unable to lock one of the superior screws in two adjacent cervical interbody cages; the surgeon decided to leave the screw holes empty.According to the agent, the screws "kept spinning" without engaging the cages.However, the surgeon was reportedly able to lock the other superior and inferior screws without any issues.Therefore, it is possible that the surgeon did not apply enough downward force to the superior screws in order to engage the cages.The patient's bone, as well as the screw/cage interface, may have also been stripped, thereby making it even more difficult to lock the screws.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 screws were discarded by the user, no physical 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 revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.User discarded.
Event or Problem Description
On 08/02/2016 it was reported to k2m, inc.That a surgery took place in which two screws were unable to be implanted.The surgery took place (b)(6) 2016.

• 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: 5919186
• Report Number: 3004774118-2016-00065
• Device Sequence Number: 10991847
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2016

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2016
• Supplement Report FDA Received Date: 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1