MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-03 for ACCUSHAPE ACSL-003 manufactured by Medcad.
[173707946]
An investigation into the event is ongoing. A follow-up report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[173707947]
Through internal review of historical cases, medcad discovered that approximately 15 months after providing an accushape patient-specific cranial implant (psci) for the patient, a second implant was provided for the same patient with the same defect, indicating that the previous accushape psci was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009196021-2020-00002 |
| MDR Report Key | 9548880 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-31 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2019-12-06 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2020-01-03 |
| 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 AVE. SUITE A1000 |
| Manufacturer City | DALLAS TX 75226 |
| Manufacturer Country | US |
| Manufacturer Postal | 75226 |
| Manufacturer Phone | 2144538864 |
| Manufacturer G1 | MEDCAD |
| Manufacturer Street | 501 S. 2ND AVE. SUITE A1000 |
| 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 | 3 |
| Brand Name | ACCUSHAPE |
| Generic Name | PEEK PATIENT-SPECIFIC CRANIAL IMPLANT |
| Product Code | GXN |
| Date Received | 2020-01-03 |
| Catalog Number | ACSL-003 |
| Lot Number | 172036 MAS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCAD |
| Manufacturer Address | 501 S. 2ND AVE. SUITE A1000 DALLAS TX 75226 US 75226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-03 |