MAUDE Adverse Event Report: K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 7601-10001

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Injury (2348)

Event Date 09/14/2019

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was confirmed via x-ray that a yukon set screw disassembled post-operatively, revision surgery has been scheduled.

Event Description

It was confirmed via x-ray that a yukon set screw disassembled post-operatively.Revision surgery was scheduled for (b)(6) 2019.

Manufacturer Narrative

Correction to d.3.And g.1.: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual analysis: device was not returned; however, x-rays were provided.Upon review, it was observed that the set screw at level c2 backed out.The x-rays revealed that the subject set screw slipped axially along the rod at the cephalic end of the construct.Dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of re-fracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid re-fracture.Periodic x-rays for at least the first year post-operatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.If the rod is not fully reduced into the tulip head, the capture strength of the set screw mechanism may be reduced, which can lead to the reported failure.The surgeon did not use reduction tool for the surgery, so the rod that was not fully reduced might have influenced the c2 set screw to migrate.Additional dynamic motion, and any unanticipated load sharing could have also contributed to the set screw migration from the construct.H3 other text : status and location of the device is unknown.

• Brand Name: SET SCREW
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9194936
• MDR Text Key: 170207274
• Report Number: 3004774118-2019-00126
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (y/n): N
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7601-10001
• Device Catalogue Number: 7601-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention