MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-28 for 2.0MM IMF SCREW SELF-DRILLING 8MM 201.928 manufactured by Oberdorf Synthes Produktions Gmbh.
[137410652]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: initial reporter is a synthes sales consultant. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[137410653]
Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent an unknown procedure. During the procedure, the holding sleeve of the intermaxillary fixation (imf) screw did not hold the head of the screws well; when the screws were placed they move a lot, making placement difficult. It was noted a lot of force was placed on two (2) self-drilling intermaxillary fixation (imf) screws to place them. It is unknown if there was a surgical delay. Procedure outcome and patient status were unknown. This report is for an intermaxillary fixation (imf) screw. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61546 |
| MDR Report Key | 8377909 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM IMF SCREW SELF-DRILLING 8MM |
| Generic Name | SCREW FIXATION INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2019-02-28 |
| Model Number | 201.928 |
| Catalog Number | 201.928 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |