MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-19 for INION S-1 SPINAL GRAFT CONTAINMENT SYSTEM UNK SPN-5221 manufactured by Inion Oy.
[31576096]
Graft subsidence is a known complication in acdf procedure. Inion s-1 product provides a more dynamic fixation than conventional metal plate, but it is not indicated to carry load. This is the first case of graft subsidence reported to inion in connection with the use of inion s-1 system. The occurrence rate of screw breakage postoperatively is 0,08% by end of 2014 and of a similar system outside the usa 0,2%. The inion s-1 devices are graft containment devices, which provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing. The devices cannot provide leverage in the fixation construct. The device shall be used in conjunction with traditional rigid fixation (i. E. , posterior interspinous wiring).
Patient Sequence No: 1, Text Type: N, H10
[31576097]
In the 8 weeks post op x-rays, surgeon observed graft subsidence in connection with acdf procedure, where inion s-1 plate and screws were used as graft containment device. Screws were observed to be broken below the plate from the upper end of the plate. In 2 weeks post-op pictures the fixation had been observed as fine. The patient was wearing a hard collar for 3 weeks after the operation. The patient has not had any symptoms, e. G. Pain, but a revision surgery was conducted to avoid any complications later.
Patient Sequence No: 1, Text Type: D, B5
[33972707]
Additional information was received concerning the patient and dates of the event. In addition, information was received that a similar adverse event (graft subsidence and screw fracture) was observed in postoperative follow-up x-ray with 4 other patients at the same clinical practice during (b)(6) 2015. According to information received, none of the patients have had clinical symptoms, e. G. Pain. Patients are ages 22-67, four females and one male. According to received information, patient outcome in all cases is good. Graft subsidence is a known complication in acdf procedure. Inion s-1 product provides a more dynamic fixation than conventional metal plate, but it is not indicated to carry load. The occurence rate of screw breakage/fracture postoperatively is 0,4% to date and including these cases; and of a similar system outside the usa 0,2%. The inion s-1 devices are graft containment devices, which provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing. The devices cannot provide leverage in the fixation construct. The device shall be used in conjunction with traditional rigid fixation (i. E. Posterior interspinous wiring).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710627-2015-00005 |
| MDR Report Key | 5235206 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-19 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-09-21 |
| Date Mfgr Received | 2015-10-18 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-11-19 |
| 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 Street | L |
| Manufacturer City | TAMPERE, 33520, FI |
| Manufacturer Country | FI |
| Manufacturer Postal | 33520, FI |
| Manufacturer Phone | 108306600 |
| Manufacturer G1 | INION OY |
| Manufacturer Street | L |
| Manufacturer City | TAMPERE, 33520, FI |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 33520, FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INION S-1 SPINAL GRAFT CONTAINMENT SYSTEM |
| Generic Name | BONE SCREW |
| Product Code | OJB |
| Date Received | 2015-11-19 |
| Model Number | UNK |
| Catalog Number | SPN-5221 |
| Lot Number | 1407001 |
| Device Expiration Date | 2017-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INION OY |
| Manufacturer Address | L??K?RINKATU 2 TAMPERE, 33520, FI FI 33520, FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-19 |