MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-19 for JETER PHARYNGEAL DISSECTOR 02-0027 manufactured by Biomet Microfixation.
[1941735]
It was reported during a procedure for a zygomatic complex fracture and repair of right orbital floor, 2mm tip of device broke off into soft tissue underneath the bone. At this time, unable to retrieve.
Patient Sequence No: 1, Text Type: D, B5
[9116251]
Visual review of instrument shows dings and gashes on both working ends. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Hospital submitted mdr also, see triage unit sequence (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1032347-2011-00054 |
| MDR Report Key | 2061863 |
| Report Source | 05,06 |
| Date Received | 2011-04-19 |
| Date of Report | 2011-03-31 |
| Date of Event | 2011-03-21 |
| Date Mfgr Received | 2011-03-31 |
| Date Added to Maude | 2011-04-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. CHRISTY CAIN |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONIVLLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047419468 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JETER PHARYNGEAL DISSECTOR |
| Generic Name | DISSECTOR |
| Product Code | GDI |
| Date Received | 2011-04-19 |
| Returned To Mfg | 2011-04-08 |
| Catalog Number | 02-0027 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-19 |