MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2010-03-18 for RTF-PLIF 12MM VERTEBRAL DRILL 82412 manufactured by Stryker Spine Bordeaux.
[17019821]
It was reported that during plif (l5-s1) surgery for stenosis, the surgeon was drilling the vertebral disc and the drill (cat #82412) went too far anteriorly, as a result, the pt had retroperitoneal bleeding. The retractor could not be used since it was too balky for the pt. The pt is now monitored in icu. The surgeon used to use the older version of the tfc vertebral cutter (cat # unk, but manufactured by (b) (4)); however, it fractured in some other surgery recently thus, it was no longer able to be used thus, he used this newer version of drill (cat #82412) for the first time.
Patient Sequence No: 1, Text Type: D, B5
[17315451]
Additional information has been requested and if made available will be reported in a supplemental.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617544-2010-00132 |
| MDR Report Key | 1637376 |
| Report Source | 00,01,07 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-03-05 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-05 |
| Date Added to Maude | 2010-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRITHIKA VELUCHAMY |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608180 |
| Manufacturer G1 | STRYKER SPINE BORDEAUX |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RTF-PLIF 12MM VERTEBRAL DRILL |
| Generic Name | INSTRUMENT |
| Product Code | LXI |
| Date Received | 2010-03-18 |
| Model Number | NA |
| Catalog Number | 82412 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE BORDEAUX |
| Manufacturer Address | CESTAS 33610 FR 33610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-03-18 |