MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-02-19 for 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW N/A 915-2315 manufactured by Biomet Microfixation.
[100409366]
(b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[100409367]
It was reported "although the screw was fixed completely at least once, after that, the screw came off from the fixed position completely during the surgery. The surgeon stated that it might cause this issue because the patient? S bone was thin. The surgery was completed using the emergency screw and the surgery delay was less than 10 minutes. " the position of the screw is reported as maxilla. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00091 |
| MDR Report Key | 7280534 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-02-19 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2017-07-28 |
| Date Added to Maude | 2018-02-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| 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 | 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW |
| Generic Name | ABSORBABLE SCREW |
| Product Code | NHB |
| Date Received | 2018-02-19 |
| Model Number | N/A |
| Catalog Number | 915-2315 |
| Lot Number | 580790 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2018-02-19 |