MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-10-19 for LEOPARD IMPLANT 5 DEGREE LORDOTIC 12MM 186448012 manufactured by Depuy Spine, Inc..
[605292]
Contact reported that the leopard implant was inserted with the inserter. While being impacted into position with the straight tamp, a small position of the implant broke off. The fragment was removed and the surgeon left the implant in place. There was no adverse patient consequence, however, as a compromised implant was left in place an mdr is being filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[7820435]
No conclusions can be made at this time. The most likely cause of the event is excessive force placed on the cage during insertion. This type of event is not unanticipated and the instructions for use (ifu) supplied with the device warns against the use of excessive force.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2006-00227 |
| MDR Report Key | 808364 |
| Report Source | 07 |
| Date Received | 2006-10-19 |
| Date of Event | 2006-09-19 |
| Date Mfgr Received | 2006-09-19 |
| Date Added to Maude | 2007-01-26 |
| 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 | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEOPARD IMPLANT 5 DEGREE LORDOTIC 12MM |
| Generic Name | INTERBODY DEVICE |
| Product Code | MRX |
| Date Received | 2006-10-19 |
| Returned To Mfg | 2006-10-18 |
| Model Number | NA |
| Catalog Number | 186448012 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 795848 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | LEOPARD IMPLANT 5 DEGREE LORDOTIC, 12MM |
| Baseline Generic Name | VBR IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 186448012 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-19 |