MAUDE Adverse Event Report: K2M, INC. DENALI SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	101-10001
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/16/2016
Type of Reportable Event	Serious Injury
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, and the exact cause of the reported issue could not be ascertained.A review of the manufacturing and inspection records did not reveal any contributing information/trends.Without the implants, it is difficult to determine whether or not the rod was fully reduced or if the set screw may have been cross-threaded.The torque handles were returned and determined to be within specification.If more information becomes available manufacturer will file a follow-up report at that time.Remains in patient.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that two set screws backed out at the distal end of the construct post-operatively.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.A review of the manufacturing and inspection records did not reveal any contributing information/trends.The set screw exhibited ideal "windshield wiper" type abrasions, which indicate an optimally seated and reduced rod, and therefore, ideal contact between the rod and set screw.While the threads exhibited signs of use, no major damage was observed.There were also no signs of cross-threading.The screw density was below one screw per level, which may have placed more stress on the set screw and contributed to it backing out.However, no root cause(s) could be determined.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that two set screws backed out at the distal end of the construct post-operatively.Patient was revised (b)(6) 2016.

• Brand Name: DENALI SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 5679127
• Report Number: 3004774118-2016-00030
• Device Sequence Number: 213213
• Product Code: NKB
• UDI-Device Identifier: 10888857003842
• UDI-Public: 10888857003842
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 101-10001
• Device Lot Number: DRJT AND DTWE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR