MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2010-05-14 for ALLEN MEDULLARY CEMENT PLUGS 00801101001 manufactured by Zimmer, Inc..
[14889285]
It is reported that the surgeon found a hair-like substance that was trapped between the tyvek and the film.
Patient Sequence No: 1, Text Type: D, B5
[15450841]
Evaluation summary: the manufactured lot was fully distributed without any further reports of this kind and appears to be an isolated instance. Cause cannot be definitively determined. Evaluation: device history records indicate all components were manufactured and inspected to specification. (b)(4). Total number of events: 1. Reason for exemption: this mdr is being submitted late, as this issue was identified during a retrospective review of complaint files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2010-00329 |
| MDR Report Key | 1694858 |
| Report Source | 01,05,08 |
| Date Received | 2010-05-14 |
| Date of Report | 2007-02-07 |
| Date of Event | 2007-02-07 |
| Date Mfgr Received | 2007-02-07 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2010-09-28 |
| 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 | BRIAN FIEDLER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN MEDULLARY CEMENT PLUGS |
| Generic Name | IMPLANT |
| Product Code | JDK |
| Date Received | 2010-05-14 |
| Returned To Mfg | 2007-05-10 |
| Model Number | NA |
| Catalog Number | 00801101001 |
| Lot Number | 60471449 |
| ID Number | NA |
| Device Expiration Date | 2011-05-31 |
| 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, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-14 |