MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-11-08 for DONJOY XX-9114-9 manufactured by Djo, Llc.
[4131925]
Complaint received that alleges "when setting the flexion setting to 70 degrees, the right side hinge tends to catch and release at 40 degrees intermittently". Product review confirmed condition on material at djo. No additional information received from pt, and/or clinician regarding additional details of incident. No indication that the device caused or contributed to permanent impairment, injury, or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00018 |
| MDR Report Key | 3618971 |
| Report Source | 04 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-10-11 |
| Date Added to Maude | 2014-03-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY |
| Generic Name | T ROM |
| Product Code | IMI |
| Date Received | 2013-11-08 |
| Model Number | XX-9114-9 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 143 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-08 |