MAUDE Adverse Event Report: K2M. INC DENALI MI SPINAL SYSTEM; PEDICLE SCREW SPINAL FIXATION

Catalog Number M101-07555

Device Problem Break (1069)

Patient Problems Pain (1994); No Information (3190)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a revision surgery took place in which a broken screw was removed.A portion of the broken screw remains in the patient.Revision surgery took place on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and thorough investigation was completed.All records revealed that all products (s) lots were manufactured within specifications.And distributed in accordance with all operating procedures.Analysis of the shear face revealed striations in the metal that were consistent with the effects of sudden stress fracture.It was reported that the patient had a non-union at this site, and had multiple operations performed at in the location over several years.This non-union combined with the compounding forces of the construct may have contributed to this specific failure nature.

Event Description

On 07.03.2018 it was reported to k2m, inc.That a revision surgery took place in which a broken screw was removed.A portion of the broken screw remains in the patient.Revision surgery took place on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review of the part, it was observed that the screw had sheared at the cannulation.Analysis of the shear face revealed striations in the metal that were consistent with the effects of sudden stress fracture.

Event Description

On (b)(6) 2018 it was reported to k2m, inc that a revision surgery took place in chich a broken screw was removed.A portion of the screws remain in the patient.Revision surgery took place on (b)(6) 2018.

• Brand Name: DENALI MI SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va VA 20175
• MDR Report Key: 7725244
• MDR Text Key: 115189389
• Report Number: 3004774118-2018-00110
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M101-07555
• Device Lot Number: UNKNOWN, HDN14
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/03/2018
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention