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

Catalog Number	3001-84560HV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
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, (b)(4) will file a supplemental report indicating the findings.Not yet returned.
Event or Problem Description
On (b)(6) 2016 it was reported to (b)(4) that a surgery took place in which a damaged connector was removed.Revision surgery took place (b)(6) 2016.
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) 2016 it was reported to k2m, inc.That a surgery took place in which a damaged connector was removed.Revision surgery took place (b)(6) 2016.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.Evaluation in process.
Event or Problem Description
On 11/25/2016 it was reported to k2m, inc.That a surgery took place in which a damaged connector was removed.Revision surgery took place (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, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.A set screw in an axial rail connector sheared in half while the surgeon was attempting to loosen it in the revision surgery.K2m, inc.Was informed that the surgeon stressed the importance of being able to "replace the damaged set screws each time [the construct is lengthened]." however, the connector's set screws are staked, so they are not designed to be completely removed.Therefore, the set screw likely sheared in half due to over-torquing it in an attempt to replace it, which is consistent with misuse.Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.(related to 3004774118-2016-00105).
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a surgery took place in which a damaged connector was removed.Revision surgery took place (b)(6) 2016.

• Brand Name: MESA SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6201959
• Report Number: 3004774118-2016-00104
• Device Sequence Number: 1610468
• Product Code: NKB
• UDI-Device Identifier: 10888857052505
• UDI-Public: 10888857052505
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/25/2016

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: 3001-84560HV
• Device Lot Number: BNGG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 01/18/2017; 02/17/2017; 03/15/2017
• 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: 3001-H45500T LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention