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

Catalog Number UNK_SPE

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

Return status of the device is unknown.

Event Description

A company representative reported that a "tulip popped off of the pelvic bolt and a rod broke." patient has been revised.This record represents the pelvic bolt.

Event Description

A company representative reported that a "tulip popped off of the pelvic bolt and a rod broke." patient has been revised.This record represents the pelvic bolt.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The 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.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.However, as no devices were available for evaluation, the root cause 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: 10077475
• MDR Text Key: 191698411
• Report Number: 3004774118-2020-00093
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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
• Date Manufacturer Received: 07/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention