MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for K2M MESA DEFORMITY manufactured by K2m.
[104565580]
Patient underwent a t10 to s2a1 instrumentation with k2m mesa instrumentation. At surgery all screws were final tightened according to manufacturer specifics. At 6 months, the rods have lost connection to the s2a1 screws at the distal end of the construct. There has been no rod failure. All hardware was in perfect position. At follow up intervals the rods remained connected until 3 months after surgery. This patient had good bone quality and underwent a scoliosis correction with internal rod reduction techniques. Eoc screws were used at s1 and t10. Rods were final tightened at all levels according to k2m specifics. The locking mechanism for the k2m mesa screw may be deficient. I have another case with the exact same problem i would be happy to share. It is my intent that the biomechanics of the final tightening mechanism be evaluated on long construct fusions in the lumbar spine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076322 |
| MDR Report Key | 7398769 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-23 |
| Date Added to Maude | 2018-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | K2M MESA DEFORMITY |
| Generic Name | LUMBAR PEDICLE SCREWS |
| Product Code | OSH |
| Date Received | 2018-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | K2M |
| Manufacturer Address | LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-04 |