MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; UNKNOWN IMPLANT

Catalog Number UNK_SPE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Respiratory Failure (2484)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

This event captures a review of a capri clinical study.No further device information is available.Patient (b)(6) experienced a prolongation of hospitalization due to acute respiratory failure and dysphagia.They were admitted to the icu and put on a ventilator post-operatively.The respiratory failure issue resolved, however, the dysphagia remains and the patient was referred to ent.

Event Description

This event captures a review of a capri clinical study.No further device information is available.Patient thirty-eight experienced a prolongation of hospitalization due to acute respiratory failure and dysphagia.They were admitted to the icu and put on a ventilator post-operatively.The respiratory failure issue resolved, however, the dysphagia remains and the patient was referred to ent.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.No device information nor additional information about the procedure was provided.There is no stryker device failure reported via this complaint therefore no investigation can be performed.If additional information is received, this investigation will be reopened and updated.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: UNKNOWN IMPLANT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11880942
• MDR Text Key: 252907102
• Report Number: 3004774118-2021-00155
• Device Sequence Number: 1
• Product Code: PLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization