MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-29 for SPF MINI 10-1398M manufactured by Ebi, Llc.
[2325148]
It was reported that an xray identified a fractured screw. Physician decided to leave the screw implanted as there has been no adverse effect or other issues associated with the event. Patient outcome: no adverse effect reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9403433]
This is 4 of 4 mdrs relating to the same reported event. Please also see mdrs: 2242816-2011-101, 2242816-2011-102, 2242816-2011-103.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242816-2011-00104 |
| MDR Report Key | 2225817 |
| Report Source | 07 |
| Date Received | 2011-08-29 |
| Date of Report | 2011-08-01 |
| Date of Event | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Date Added to Maude | 2011-09-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ART KAUFMAN |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF MINI |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2011-08-29 |
| Catalog Number | 10-1398M |
| Device Expiration Date | 2012-02-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-29 |