MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-07-29 for POLARIS SPINAL SYSTEM PLUG STARTER N/A 14-500170 manufactured by Biomet Spine - Broomfield.
[6253826]
The sales associate reported they just finished a case and the patient has responded well thus far, however the patient's spinal cord was exposed and the plug driver failed to operate in a proper fashion causing a dural tear at the cervicothoracic (ct) junction. He also reports a surgical delay of one hour before they could continue the surgery. Upon follow up with the surgeon directly after the event, he stated "patient had a loss of mep (multimodality evoked potential) data and possible spinal cord injury. We will see tomorrow since he is still intubated, left upper extremity motors were lost in the case and never got back to baseline. " patient outcome: upon follow up with the sales associate, he reports "patient is doing fine post op with no deficit. "
Patient Sequence No: 1, Text Type: D, B5
[13965149]
Without a product return, no product evaluation is able to be conducted. 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.
Patient Sequence No: 1, Text Type: N, H10
[26037931]
(b)(4). A follow up report will be sent upon competition of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[33948878]
The returned part (b)(4) (plug starter with fixed handle) from lot 565995 was visually inspected and did not display evidence of damage or misuse. The plug starter maintains its manufactured specifications, verified using a caliper in reference with product drawings. A functional test of the plug starter was performed by mating the starter with a polaris 5. 5 helical flange plug test gage and driving the plug into the 5. 5 x 5. 5mm open-open saddle (p/n (b)(4)). The plug starter successfully performed in the? Stab and grab? Inspection test outlined in the product? S inspectional dimensional record and operated as it is advised in the polaris 5. 5 surgical technique guide. The plug stuck to the starter and was able to properly thread on the screw? S saddle without cross threading. The instrument exhibits signs of wear consistent with use to tighten the mating plugs in the construct. This wear may be a result of the surgeon using the plug starter to tighten the plugs without use of the appropriate driver and torque handle. The probable root cause of the reported instrument failure can be attributed to improper use by the end-user. Updated based on the completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004485144-2015-00017 |
| MDR Report Key | 4950146 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-07-29 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2014-04-29 |
| Date Added to Maude | 2015-07-29 |
| 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 SPINAL SYSTEM PLUG STARTER |
| Generic Name | PLUG STARTER WITH FIXED HANDLE |
| Product Code | HWD |
| Date Received | 2015-07-29 |
| Returned To Mfg | 2015-08-13 |
| Model Number | N/A |
| Catalog Number | 14-500170 |
| Lot Number | 565995 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Deathisabilit | 2015-07-29 |