MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for ENDOSKELETON? TT 4200-1021 manufactured by Titan Spine, Llc.
[39423393]
A review of the device history records was performed for the subject device. The review revealed there were no issues during the manufacture of the lot of the subject device that would contribute to this complaint condition. The lot of the subject device conformed and passed the inspection record. The subject device was not returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined. Attempts have been made to retrieve the subject device (see attached emails). An investigation and update report will be completed if the subject device is returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[39423394]
The surgeon was performing a posterior lumbar decompression at l5-s1 with interbody fusion at l5-s1 with titan tt and pedicle screws at l5 and s1 with depuy matrix. The surgeon was in-serviced how to use the device pre-op. The disc space was adequately cleared of cartilage and the space was removed and the space was trialed with a 10mm tt trial. The surgeon tapped the tt implant into the intervertebral area to the agreed upon depth and then the inserter handle was removed. The forked instrument (tt thin pusher) used to turn the tlif implant was introduced and placed against the implant in correct orientation. The surgeon moderately hammered the instrument transfer force into the tt spacer, but the spacer would not move. After several attempts, the surgeon looked at the tips to re-insert correctly into the implant and this is when the surgeon noticed the tip had broken off. Recent x-rays and additional x-rays were taken and examined; however, these did not identify the loose piece of the metal tip. The surgeon and rep made a determination that the broken piece must have been taken out by the sucker that is commonly used to remove blood from the working area. The surgeon also applied copious amounts of saline to flush out the area. The implant stayed in the orientation of an oblique cage. It was positioned well and firmly in-between l5 and s1. The surgeon was fine with its position even though they didn't get the implant to "turn" (pivot the implant to align with the anterior surface as the tt thin pusher is designed to function). This broken instrument added just a few minutes to the case, but the surgeon was disappointed the primary tool used to turn the implant rendered useless. There were no adverse effects or injury to the patient as a result of the tt pusher breaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006340236-2016-00001 |
| MDR Report Key | 5448567 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-16 |
| Date of Event | 2016-01-19 |
| Date Mfgr Received | 2016-01-20 |
| Date Added to Maude | 2016-02-19 |
| 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. JEFF GROSKOPF |
| Manufacturer Street | 6140 W. EXECUTIVE DR. STE A |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal | 53092 |
| Manufacturer Phone | 2622427801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOSKELETON? TT |
| Generic Name | THIN PUSHER |
| Product Code | HXO |
| Date Received | 2016-02-19 |
| Catalog Number | 4200-1021 |
| Lot Number | N141131 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TITAN SPINE, LLC |
| Manufacturer Address | 6140 W. EXECUTIVE DR. STE A MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |