MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-06 for AIC CUSTOMIZED INSTRUMENT AESCULAP0331 manufactured by Aesculap Inc.
[178330241]
Manufacturing evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if applicable.
Patient Sequence No: 1, Text Type: N, H10
[178330242]
It was reported that there was an issue with the customized instrument. The extended osteotome broke in half during a lumbar fusion procedure. There was no surgical delay. There was no patient harm or intervention required. It was stated that there had been no corrosion noted and type of sterilization used was 275/10/40 prevac.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00003 |
| MDR Report Key | 9555708 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2020-01-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIC CUSTOMIZED INSTRUMENT |
| Generic Name | MISCELLANEOUS |
| Product Code | GFI |
| Date Received | 2020-01-06 |
| Model Number | AESCULAP0331 |
| Catalog Number | AESCULAP0331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |