MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-01 for UNKNOWN VIPER 2 UNILATERAL manufactured by Depuy Synthes Spine.
[5617691]
Revision of viper 2 unilateral, cfx screw and confidence cement, l3-iliac crest performed on (b)(6) 2015 by dr (b)(6). The patient underwent revision surgery as the patient had fused on 1 side, but had not fused on the other side. This was identified from an x-ray, which highlighted black areas around the screws which the product specialist has described as haloing. (b)(6) 2015 - update - clearer complaint description received. On an unspecified date, approximately 5 years ago, the patient underwent surgery from l3? Iliac crest and a viper 2 system was implanted. Recently an x-ray was taken, it was identified from the x-ray that the patient had fused on 1 side, but not on the other side (black areas / haloing seen around the screws on the x-ray). Therefore, on (b)(6) 2015, the patient underwent a unilateral revision surgery. Some screws of the viper 2 system were removed. The surgeon implanted a cfx screw and confidence cement.
Patient Sequence No: 1, Text Type: D, B5
[13178053]
A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Sample not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2015-10238 |
| MDR Report Key | 4650581 |
| Report Source | 01,05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-02 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-02 |
| Date Added to Maude | 2015-04-02 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL JACENE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776485 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN VIPER 2 UNILATERAL |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2015-04-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-01 |