MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for DIGITAL SURGICAL PLANNING DSP-100 manufactured by Osteomed.
[120120849]
On (b)(6) 2018, osteomed was notified of an adverse event related to the single jaw orthognathic splint. Per the information received, the patient had a orthognathic double-jaw surgery on (b)(6) 2018. The procedures included a le fort i maxillary osteotomy, bilateral sagittal split mandibular osteotomy and a genioplasty. The splints are used to align the bones and facial structures in place to then be fixated by plates and screws. The surgery was deemed successful on (b)(6) 2018. However, when the patient came back in for his post-op follow up with the physician (approximately 6-8 weeks later), his dental midline was off by 2 millimeters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2018-00039 |
| MDR Report Key | 7865109 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-07-13 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-09-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ESTELLE ANUWE |
| Manufacturer Street | 501 S. 2ND AVENUE SUITE A-1000 |
| Manufacturer City | DALLAS TX 75226 |
| Manufacturer Country | US |
| Manufacturer Postal | 75226 |
| Manufacturer G1 | MEDCAD |
| Manufacturer Street | 501 S. 2ND AVENUE SUITE A-1000 |
| Manufacturer City | DALLAS TX 75226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIGITAL SURGICAL PLANNING |
| Generic Name | SINGLE JAW ORTHOGNATHIC SPLINT |
| Product Code | ELS |
| Date Received | 2018-09-11 |
| Catalog Number | DSP-100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-11 |