MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-13 for VIPER PRIME COMP DRIVER, X25 286750083 manufactured by Medos International Sàrl Ch.
[154129528]
(b)(4). The device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate
Patient Sequence No: 1, Text Type: N, H10
[154129529]
It was reported that this was a posterior spinal fusion procedure treating spinal stenosis for the lumbar spine on (b)(6) 2019. While the surgeon was using the vprp compressor driver (286750083) with a compressor driver leg and a compressor solid leg, the tip of the compressor driver broke and stuck in a setscrew? S thread hole. The surgeon completed the procedure within a 30-minute delay, leaving the fragment in the patient? S body. The surgeon commented that excessive load was put during the compression. This complaint involves one (1) device.
Patient Sequence No: 1, Text Type: D, B5
[176715031]
Product complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2019-51963 |
| MDR Report Key | 8887973 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-13 |
| Date of Report | 2019-07-25 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2016-08-22 |
| Date Added to Maude | 2019-08-13 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIPER PRIME COMP DRIVER, X25 |
| Generic Name | INSTRUMENT, COMPRESSION |
| Product Code | HWN |
| Date Received | 2019-08-13 |
| Returned To Mfg | 2019-08-16 |
| Model Number | 286750083 |
| Catalog Number | 286750083 |
| Lot Number | KM857447 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-13 |