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 2016-04-29 for POLARIS 5.5 TI 60MM TI CURVED ROD N/A 2000-5160 manufactured by Biomet Spine - Broomfield.
[44009223]
The implants are titanium alloy. The user facility is foreign; therefore a facility medwatch report will not be available. Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Report five of five for the same event; see also 3004485144-2016-00054 through 00057. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[44009224]
The sales associate reported that a patient underwent a surgery in 2012 in which a polaris was implanted. An allergy to some components such as cobalt chloride, golden sodium bisulfite and nickel has been detected to the patient. It is reported no revision surgery is planned at this time and the surgeon does not think the patient's symptoms are related to the implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2016-00058 |
| MDR Report Key | 5619382 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-29 |
| Date of Report | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| Date Added to Maude | 2016-04-29 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLARIS 5.5 TI 60MM TI CURVED ROD |
| Generic Name | ROD |
| Product Code | OSH |
| Date Received | 2016-04-29 |
| Model Number | N/A |
| Catalog Number | 2000-5160 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-29 |