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	06/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product has not been returned to manufacturer for evaluation, and a thorough investigation could not be completed at this time as no lot number has been identified/confirmed in this case.Once more information becomes available manufacturer will file a follow-up report at that time.Not returned.
Event or Problem Description
It was reported k2m inc on (b)(6) 2016 that two set screws backed out almost four years post-op.The patient was revised (b)(6) 2016.
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.Visual inspection of the bottom of one of the set screws exhibited abrasions indicative of insufficient rod contact.Similarly, one of the connectors that were returned exhibited abrasions near the end of its rod portion.Therefore, it is likely that the set screw backed out due to insufficient rod reduction and set screw contact during final tightening.A review of the manufacturing and inspection records did not reveal any contributing information/trends.
Event or Problem Description
It was reported k2m inc on (b)(6) 2016 that two set screws backed out almost four years post-op.The 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: 5808068
• Report Number: 3004774118-2016-00052
• Device Sequence Number: 13571246
• 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: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2016

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 101-10001
• Device Lot Number: BGFY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 08/11/2016
• 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: 70 YR