MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-02 for TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM 04.500.026.01 manufactured by Synthes Usa.
[5892807]
It was reported that when the patient came in for follow up, the surgeon noted orthodontic bone anchor (oba) plate and screw construct is loose. Surgeon is planning to remove implants on (b)(6) 2015 and replace with new implants. This is report 7 of 16 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13285006]
Additional narrative: patient information is unknown device is planned to be explanted on (b)(6) 2015, but has not been explanted yet. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[27225448]
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 The medwatch reports for this device are hereby rescinded.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
[27225449]
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 (b)(6) 2015. Additional devices, which were not related to this complaint, were mistakenly reported with the actual complained devices for (b)(4). After additional investigation, it was determined that only a quantity of six each of part number, 04. 500. 026. 01, were associated with the complained event and received for evaluation, not ten as previously reported. The additional four devices were reported in error. The medwatch reports for this device are hereby rescinded.
Patient Sequence No: 1, Text Type: D, B5
[27452282]
A total of seven (7) unknown screws were returned. It is unknown at this time which screws were received. A revision procedure took place on (b)(6) 2015. It is unknown if this is one of the explanted screws. (b)(4). Device 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
[27452283]
Update: it was reported that the patient was being treated with orthodentic bone anchors (oba). During a follow up visit, the surgeon noticed that two (2) oba plates in maxilla were becoming loose. The surgeon brought the patient back to his office where he removed the hardware in maxilla (two plates and six screws) and replaced it with new oba plates and screws. The revision procedure was successfully performed on (b)(6) 2015 with no surgical delay noted. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-14163 |
| MDR Report Key | 4811013 |
| Report Source | 05,07 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-11 |
| Date Mfgr Received | 2015-07-16 |
| Date Added to Maude | 2015-06-02 |
| 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 6MM |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2015-06-02 |
| Catalog Number | 04.500.026.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-02 |