MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number UNK_SPE

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

Return status of the device is unknown.

Event Description

A physician reported that a patient underwent revision surgery to address an ozark plate which had migrated post-operatively with two screws still locked in place.This record represents the second of the two screws.

Manufacturer Narrative

Correction to d.3.And g.1.: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual, 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.Review of the relevant ifu, surgical protocol, and package labelling could not be performed since the device associated with this event was not returned nor was it properly identified.No adverse consequences or severe issues were reported and it is unclear whether revision surgery was required or if was performed.No investigation conclusion could be determined since the product was never identified and insufficient information was provided.

Event Description

A physician reported that a patient underwent revision surgery to address an ozark plate which had migrated post-operatively with two screws still locked in place.This record represents the second of the two screws.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9153158
• MDR Text Key: 167022954
• Report Number: 3004774118-2019-00112
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: K171704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: 05/21/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention