MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST® SPINAL SYSTEM; THOROCOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 2911-06550

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That a polyaxial and set screw backed-out, loosened or disengaged approximately 24 months post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00014).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.It was determined that the polyaxial screw was a concomitant device and did not contribute to the event.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That a set screw backed out, loosened or disengaged approximately 24 months post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00014).

• Brand Name: EVEREST® SPINAL SYSTEM
• Type of Device: THOROCOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8371968
• MDR Text Key: 137241206
• Report Number: 3004774118-2019-00013
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2911-06550
• Device Lot Number: FNYJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2901-10001 LOT FGGV; 2901-10001 LOT FGGV
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 73