MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-05 for DISTRACTION DRILL GUIDE F/FF901&FF903 FF907R (DEVICE 3) manufactured by Aesculap, Inc..
[21394471]
Surgeon was in the process of drilling holes in the vertebral bodies in order to place caspar distraction pins. The scrub tech handed him in fj840r (abc drill bit-device 1) (loaded in the angled handpiece of the hilan drill) and the ff907r (distraction pin drill guide-device 3). The surgeon proceeded to drill the hole, the rill proceeded to pass beyond the posterior cortex, past the pll (posterior lateral ligament) and into the spinal cord. Surgery prolonged approximately 30minutes).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2005-00021 |
| MDR Report Key | 600041 |
| Report Source | 07 |
| Date Received | 2005-05-05 |
| Date of Report | 2005-05-05 |
| Date of Event | 2005-02-15 |
| Date Mfgr Received | 2005-04-14 |
| Date Added to Maude | 2005-05-10 |
| 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 | 0 |
| Manufacturer Contact | DEE SCHLUETER |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISTRACTION DRILL GUIDE F/FF901&FF903 |
| Generic Name | GUIDE, SURGICAL INSTRUMENT |
| Product Code | HXY |
| Date Received | 2005-05-05 |
| Model Number | NA |
| Catalog Number | FF907R (DEVICE 3) |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 589880 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US |
| Baseline Brand Name | DISTRACTION DRILL GUIDE F/FF901&FF903 |
| Baseline Generic Name | GUIDE, SURGICAL INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | FF907R (DEVICE 3) |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-05 |