MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-10-28 for ANKYLOS UNSCREW INSTRUMENT FOR COVER SCREWS 31033434 manufactured by Friadent Gmbh.
[2340650]
In this event it was reported that an ankylos unscrew instrument for cover screws separated from the handle and was swallowed by a pt during a surgical treatment. The pt had a very thick gingiva, so the cover screw caught under the gingiva and thus the tool separated from the handle. Only the handle had been secured, as a result, the pt went to the hosp, where an attempt was made to remove the tool via endoscopy. However, the endoscopy was unsuccessful because the instrument had already left the pt's stomach. Meanwhile, the instrument was excreted and is therefore not available for eval. According to the doctor, the pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[9423173]
Because this event necessitated in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body structure, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681851-2011-00028 |
| MDR Report Key | 2316891 |
| Report Source | 01,05 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-09-28 |
| Date Mfgr Received | 2011-09-28 |
| Date Added to Maude | 2011-11-02 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST. STE 60 SUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | FRIADENT GMBH |
| Manufacturer Street | STEINZEUGSTRASSE POSTFACH 710261 |
| Manufacturer City | MANNHEIM 68229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANKYLOS UNSCREW INSTRUMENT FOR COVER SCREWS |
| Product Code | NPZ |
| Date Received | 2011-10-28 |
| Catalog Number | 31033434 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRIADENT GMBH |
| Manufacturer Address | MANNHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-28 |