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

Catalog Number 101-N55300

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was not returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(4) 2017 it was reported to k2m, inc.That a patient presented with a rod break approximately 9 months post-operatively.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the rod remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.The surgical history indicated progression and adjacent level degeneration.Review of the fluoro imagery resulted in an observation of rod fracture between the l2-l3 levels with the break occurring through the rod bend which is located at the cephalad end of the lower construct.Pseudarthrosis or progressive degeneration could contribute to over load or fatigue to an existing rod construct.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a rod break approximately 9 months post-op.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.The surgical history indicated progression and adjacent level degeneration.Review of the fluoro imagery resulted in an observation of rod fracture between the l2-l3 levels with the break occurring through the rod bend which is located at the cephalad end of the lower construct.Pseudarthrosis or progressive degeneration could contribute to over load or fatigue to an existing rod construct.Further investigation upon return of the subject device confirmed metal fatigue leading to rod fracture.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a rod break approximately 9 months post-op.On (b)(6) 2018 it was reported that the patient was revised.

• Brand Name: DENALI SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.,; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.,; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192195
• MDR Report Key: 6896939
• MDR Text Key: 88863072
• Report Number: 3004774118-2017-00134
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 101-N55300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR