MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problem Material Separation (1562)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

A physician reported that two keys tulips have separated from the respective screw shafts.Revision surgery is scheduled for approximately six months in the future.This report capture the first of two screws.

Event Description

A physician reported that two keys tulips have separated from the respective screw shafts.Revision surgery is scheduled for approximately six months in the future.This report capture the first of two screws.

Manufacturer Narrative

The device has not been returned for evaluation.Manufacturing records and complaint history could not be reviewed neither a catalogue or lot number were provided.There were no complications reported during the initial surgery.Activity level of the patient after initial surgery was not reported.The surgeon reported that the patient did not experience any trauma after initial surgery.The surgical technique instructs that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.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 refracture in an active individual.An exact cause of the reported event could not be determined conclusively.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10479836
• MDR Text Key: 205263767
• Report Number: 3004774118-2020-00193
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR