MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for ACTIV C IMPLANT FLAT SIZE XXL 5MM SW299K manufactured by Aesculap Implant Systems.
[98985129]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[98985130]
(b)(6). The first prosthesis was not properly stored in the packaging. Both parts cranial/caudal were not in the designated receptacle (inner packaging). When implanted into the intervertebral space, the implant was too loose on the insert instrument and dislodged/displaced when inserted into the intervertebral space and was also removed. The second implant was then opened and it was immediately seen that in the inner packaging both parts were not in the designated receptacle. Thereafter, the next size was taken, but the bone or the intervertebral space had to be further milled to fit this size. Surgery delay approx. 40 min. Components in use listed as concomitant devices are: sw299k / activ c implant flat size xxl 5mm, fw863r / activ c spacer h5mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00029 |
| MDR Report Key | 7232635 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-02-21 |
| Date Facility Aware | 2018-01-15 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2013-06-28 |
| Date Added to Maude | 2018-01-31 |
| 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. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACTIV C IMPLANT FLAT SIZE XXL 5MM |
| Generic Name | ACTIV C IMPLANTS |
| Product Code | LYQ |
| Date Received | 2018-01-31 |
| Returned To Mfg | 2018-01-19 |
| Model Number | SW299K |
| Catalog Number | SW299K |
| Lot Number | 51951682 |
| Device Expiration Date | 2018-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-31 |