MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-05 for SKIPJACK EXPANDABLE INTERBODY SYSTEM manufactured by Seaspine Inc..
[129593034]
Radiographs received depicted an interbody backing out of the vertebral body. No product id information, lot number, case report or explants have been received. Dhr review and product investigation cannot be completed, as the device remains in-situ. Revision surgery is planned for early december. Review of labeling notes: postoperative warnings: the patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised that implants may bend, break or loosen despite restriction in activity. Possible adverse events: bending, disassembly or fracture of implant and components. Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain. It is unknown if the patient sustained a fall. The patient's anatomical condition and the effects on the stability of the implant and/or construct may be unknown contributing factors. The root cause of this event cannot be determined. No conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[129593035]
On (b)(6) 2018 patient underwent a one level spinal fusion with skipjack posterior interbody and mariner fixation system. Follow-up exam radiographs showed the skipjack interbody is backing out posteriorly. Patient is asymptomatic. Revision surgery is scheduled for (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012120772-2018-00029 |
| MDR Report Key | 8136113 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-12-05 |
| 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 | AARON |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7602165109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIPJACK EXPANDABLE INTERBODY SYSTEM |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2018-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE INC. |
| Manufacturer Address | 5770 ARMADA DRIVE CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-05 |