MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-06 for IN-SPACE IMPLANT 14MM-STERILE 04.630.014S manufactured by Synthes Mezzovico.
[13091508]
Additional narrative: subject device has been received and is currently in the evaluation process. An investigation summary was performed. The investigation of the complaint articles has shown that: all four wings are still un-deployed and partially broken. In addition circular marks are clearly visible on the connecting end of the implant. Based on this finding we have to assume that the implant was not attached correctly onto the implant holder (the slots of the implant did not match with the tappets of the implant holder), resulting in a wrong orientation of the implant and finally preventing the deployment of the wings as the wings were covered by the wall of the sleeve. The manufacturing documents were reviewed and no complaint related issues were found. This lot of (b)(4) pieces was manufactured in september 2010, all parts are sold and we are not aware of any other complaint for this article and lot number. No product fault could be detected. No product fault could be detected. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[15644055]
Device was used for treatment, not diagnosis. Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[20016531]
It was reported that while preparing the instruments used in this case for another case, it was noticed that the instruments were broken, damaged or defective. It is thought the broken instruments are related to the broken implant from the procedure.
Patient Sequence No: 1, Text Type: D, B5
[20282331]
Additional narrative: device was not implanted/explanted. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[21551008]
Device report from synthes europe reports an event in (b)(6) as follows: during the surgery at the time of the introduction of the implant, the device wings are not fully open and break. The implant was removed from the patient. The surgery was prolonged about 20 minutes due to the reported device issue. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21596668]
Patient identifier and age were not provided by reporter. 510(k) device is not distributed in the united states, but is similar to device marketed in the usa. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The subject device was received. The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000562954-2015-10060 |
| MDR Report Key | 4578082 |
| Report Source | 01,07 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-25 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2010-09-10 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MEZZOVICO |
| Manufacturer Street | ZONA INDUSTRIALE 4 |
| Manufacturer City | MEZZOVICO CH6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN-SPACE IMPLANT 14MM-STERILE |
| Generic Name | IMPLANT, FIXATION, DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2015-03-06 |
| Returned To Mfg | 2015-03-06 |
| Catalog Number | 04.630.014S |
| Lot Number | AA1769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MEZZOVICO |
| Manufacturer Address | ZONA INDUSTRIALE 4 MEZZOVICO CH6805 SZ CH6805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |