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

Catalog Number 801-06540

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was 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)(6) 2018 it was reported to k2m, inc.That a surgery took place in which two screws broke at the shaft approximately 24 months post-operatively.The shafts of the screw remained in the patient.Patient was revised on (b)(6) 2018.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which two screws broke at the shaft approximately 24 month post-operatively.The shafts remain in the patient.Patient was revised 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 a thorough investigation was completed.Upon review of one of the screws (lot dguh), it was observed that the screw had sheared at the shaft, starting at the beginning of the proximal thread.Analysis of the shear face revealed that the screw failed in brittle fracture.Upon review of one of the screws (lot dlfy), it was observed that the screw had sheared at the shaft, towards the medial end of the shaft.Analysis of this shear face revealed that the screw failed in brittle fracture.The manufacturing and inspection records were reviewed and no relevant discrepancies were found.

• Brand Name: MESA SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 7858649
• MDR Text Key: 119644871
• Report Number: 3004774118-2018-00135
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: 801-06540
• Device Lot Number: DGUH06D, DLFY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/08/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 101-65550 LOTS BMRC, CCTH 801-06545 LOTS DWYU,DLGA; 101-65550 LOTS BMRC,CCTH 801-0645 LOTS DWYU,DLGA
• Patient Outcome(s): Required Intervention