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 2019-04-25 for NUVASIVE? VERSATIE SYSTEM 8510260 manufactured by Nuvasive Inc..
[143031996]
The product was returned and tested according to specifications. No radiographs or images were provided to confirm the alleged event. As per reporter the band positioning was higher than intended and recommended creating excessive prying force. Even though root cause cannot be confirmed, root cause may be related a procedural error. Follow up technique variation has been provided to involved staff. No product failure was identified. Labeling review: "... Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient... " "... Potential risks identified with the use of this system, which may require additional surgery, include:? Disassembly, fraying, kinking, loosening, bending or breakage of any or all of the versatie system implant components? Loss of fixation? Nonunion or delayed union? Fracture of the vertebra.. " "... Step 1: create spinous process hole use the provided bone punch or 3. 5 mm burr to create a hole in the spinous process once the screws are placed, prior to inserting the rod. Once the hole has been created, the rod can then be placed (fig. 9). Step 2: load connector reference sub-laminar fixation step 1. Step 3: pass band pass the needle tip of the band through the newly created hole. Use the needle driver to grip the thick rope portion (not the needle), and pull the band laterally through until both ends are even (fig. 10). Tip when using the bone punch, place the tips on either side of the spinous process as ventral as possible, squeeze the arms, and rock the instrument in the cranial/caudal direction to create a through hole... "
Patient Sequence No: 1, Text Type: N, H10
[143032157]
On (b)(6) 2019 a patient underwent a posterior fixation procedure utilizing the versatie system. As per reporter while tension was being performed the band ripped the spinous process. The surgeon moved to the next level and the same thing occurred. Alternative fixation device was utilized. The patient was reported to have re-cooperated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2019-00187 |
| MDR Report Key | 8547866 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-04-25 |
| 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. GEORGE PANFILI |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer G1 | NUVASIVE |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE? VERSATIE SYSTEM |
| Generic Name | BONE FIXATION CERCLAGE, SUBLAMINAR |
| Product Code | OWI |
| Date Received | 2019-04-25 |
| Model Number | 8510260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 8450001 | 1. Other | 2019-04-25 |