MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-07-02 for TI OBA PLATE ANCHOR SCREW SELF-DRILLING 4MM 04.500.024.01 manufactured by Synthes Usa.
[6071509]
Patient was being treated with orthodontic bone anchors (oba). On follow up visit, surgeon noticed two (2) oba plates in maxilla were becoming loose. Surgeon brought patient back to his office where he removed hardware in maxilla and replaced it with new oba plates and screws. Procedure was done on 6/5/15. There was no surgical delay. Patient is doing well. This is report 17 of 17 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13521438]
Additional narrative: patient weight is unknown. Without a lot number the device history records review could not be completed. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[27229249]
After additional investigation, it was determined that this device was not associated with the reported event. The medwatch reports for this device are hereby rescinded. The previous medwatch reports for this device were submitted in error. 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
[27229250]
Additional information was obtained after this complaint file was re-reviewed and further clarification of the devices involved in the reported event were obtained from the reporter on july 16, 2015. Additional devices, which were not related to this complaint, were mistakenly reported and/or returned with the actual complained devices for (b)(4). After additional investigation, it was determined that part number, 04. 500. 024. 01, was not associated with the reported event. The medwatch reports for this device are hereby rescinded.
Patient Sequence No: 1, Text Type: D, B5
[27237827]
A product development investigation was performed for the subject device (part number, 04. 500. 024. 01, 1. 55mm midface self-drilling screw, lot number unknown). The subject device was returned in good condition with no functional damage and only minor marring around the hex drive. Due to the nature of the complaint, the complaint condition was unable to be replicated or verified. The cause of the complaint condition could not be determined. A visual inspection and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. This complaint is unconfirmed. 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
| Report Number | 2520274-2015-14772 |
| MDR Report Key | 4888051 |
| Report Source | 05,07 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-06-24 |
| Date Mfgr Received | 2015-07-16 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI OBA PLATE ANCHOR SCREW SELF-DRILLING 4MM |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2015-07-02 |
| Returned To Mfg | 2015-06-17 |
| Catalog Number | 04.500.024.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-02 |