MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-19 for STALIF M FLX CAGE 36MM X 13MM X 16DEG SMF361316 manufactured by Centinel Spine, Llc..
[188000125]
The patient received a 2-level stalif m flx construct on (b)(6) 2020 at l4-l5 and l5-s1. The patient was indicated to be obese with poor bone quality. This patient condition may have contributed to the reported event. During post-operative follow-up, lateral x-ray images found that the stalif m flx cage subsided into the l5 vertebral body. This caused 2 of the 3 stalif midline screws implanted at l4-l5 to back out of the construct. The patient was not experiencing any signs or symptoms including pain. The pain the patient was experiencing pre-operative was gone. The surgeon elected to revise the patient by removing the 2 backed out screws and adding posterior fixation to stabilize the implant. One of the 3 screws and the cage were left implanted in the patient. Review of the device history records did not find any issues during manufacturing that may have caused or contributed to this event. The risk assessment for the involved devices identified, mitigated, and determined the risks associated with this event are acceptable. Trend analysis found the rate of this event is within the limits established in the risk assessment. If additional information becomes available, this report may be updated appropriately.
Patient Sequence No: 1, Text Type: N, H10
[188000126]
A patient required a revision surgery on (b)(6) 2020 to remove 2 stalif midline screws which had backed out of the l4-l5 stalif m flx construct due to subsidence of the cage into the l5 vertebrae. The screw back out and subsidence was noted during routine post-operative follow-up on (b)(6) 2020. The surgeon elected to remove the screws due to the aggressive screw back out and location to blood vessels to preclude serious injury. In addition to the screw removal, posterior fixation was added to stabilize the implant. The patient did not present with any signs or symptoms related to the screw back out at the follow-up appointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007494564-2020-00006 |
| MDR Report Key | 9729220 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-02-15 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JASON SMITH |
| Manufacturer Street | 900 AIRPORT RD, SUITE 3B |
| Manufacturer City | WEST CHESTER, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8878839 |
| Manufacturer G1 | TANGIBLE SOLUTIONS INC. |
| Manufacturer Street | 678 YELLOW SPRINGS-FAIRFIELD R |
| Manufacturer City | FAIRBORN, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STALIF M FLX CAGE 36MM X 13MM X 16DEG |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-02-19 |
| Model Number | SMF361316 |
| Lot Number | 2018-1150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTINEL SPINE, LLC. |
| Manufacturer Address | 900 AIRPORT RD, SUITE 3B WEST CHESTER, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |