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

Catalog Number 2901-10001

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 07/10/2017

Event Type  Injury  

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 Description

On 07.28.2017 it was reported to k2m, inc.That a revision surgery took place in which set screws were removed.Revision surgery took place (b)(6) 2017.

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 screw was discarded, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It was not indicated as to which torque handle was used to final tighten the set screw - the torque limiting (i.E., clutch-style) handle or torque indicating (i.E., line-to-line) wrench.Because clutch-style torque handles are speed dependent (i.E., as rotational speed increases, output torque decreases), it is possible that the surgeon's torquing technique contributed to this incident if the handle was turned quickly.It is also possible that the rods were not fully reduced in the heads of the pedicle screws, and the set screws torqued off prior to seating fully in the screw heads, predisposing the pedicle screws to axial slip and early set screw back outs.

Event Description

On 07/28/2017 it was reported to k2m, inc.That a patient presented with a post-operative set screw back-out.The patient was revised (b)(6) 2017.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719195195
• MDR Report Key: 6821674
• MDR Text Key: 83686282
• Report Number: 3004774118-2017-00108
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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
• Device Operator: Physician
• Device Catalogue Number: 2901-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79