MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-12 for BAK / L DISTRACTION PLUG INSERTER 4021-0031-00 manufactured by Zimmer Spine, Inc..
[1214053]
During surgery, the inserter broke as the physician was impacting the plug into the intervertebral space. The physician removed the plug without any negative impact or complications.
Patient Sequence No: 1, Text Type: D, B5
[8353130]
Device history record reviewed. Review of device history records indicate the device was manufactured specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2009-00016 |
| MDR Report Key | 1432691 |
| Report Source | 07 |
| Date Received | 2009-05-12 |
| Date of Report | 2009-04-15 |
| Date of Event | 2009-04-15 |
| Date Mfgr Received | 2009-04-15 |
| Device Manufacturer Date | 1997-09-25 |
| Date Added to Maude | 2010-03-16 |
| 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 | ANNETTE DOXON |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 554392027 |
| Manufacturer Country | US |
| Manufacturer Postal | 554392027 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAK / L DISTRACTION PLUG INSERTER |
| Generic Name | DISTRACTION PLUG INSERTER |
| Product Code | LSH |
| Date Received | 2009-05-12 |
| Returned To Mfg | 2009-04-24 |
| Model Number | 4021-0031-00 |
| Catalog Number | 4021-0031-00 |
| Lot Number | P970102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-12 |