MAUDE Adverse Event Report: K2M, INC. CAYMAN THORACOLUMBAR PLATE SYSTEM; THORACOLUMBAR PLATES

Catalog Number	1201-16028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible screw back-out.The patient reportedly had possible screw back-out approximately 2 months post-op.There are no plans to revise at this time.The patient is asymptomatic.
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.The surgeon acknowledged that the patient was very active and appeared to have been over-active prior to their one-month follow-up.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported that a patient presented with a possible screw back-out.The patient reportedly had possible screw back-out approximately 2 months post-op.There are no plans to revise at this time.The patient is asymptomatic.

• Brand Name: CAYMAN THORACOLUMBAR PLATE SYSTEM
• Common Device Name: THORACOLUMBAR PLATES
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6460500
• Report Number: 3004774118-2017-00026
• Device Sequence Number: 591802
• Product Code: KWQ
• UDI-Device Identifier: 10888857018617
• UDI-Public: 10888857018617
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: 1201-16028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1208-42F40 LOT UNKNOWN