MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-22 for NASAL DARTT IMPLANT - 40M X 4M 84008 manufactured by Stryker Orthobiologics-malvern.
[5746937]
It was reported that the implant broke in half at the hinge prior to insertion. It was reported that a second implant was used to complete the case. The surgical delay was less then five minutes.
Patient Sequence No: 1, Text Type: D, B5
[13173983]
The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34104475]
The reported event could not be confirmed. The failure mode (intraoperative breakage) could not be attributed to a certain root cause, because the device was not returned. The related dhr showed that the device has been manufactured according to the specification. The device is very thin and overall a lightweight construction. According to the related design risks analysis these are possible root causes for the reported failure: 1. Or team inexperienced with medpor implants, insufficient education or instruction; 2. Too much force. Since the second implant worked as intended most likely too much forces acted on the implant and resulted in the breakage. According to the sales rep the implant had been used for a plastic surgery of the face/nose, where no load bearing appears. During the statistical investigation no indication was found for any systematic, material or manufacturing related issue. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[34104476]
It was reported that the implant broke in half at the hinge prior to insertion. It was reported that a second implant was used to complete the case. The surgical delay was less then five minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2015-00083 |
| MDR Report Key | 4717080 |
| Report Source | 04 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2015-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JONATHAN SCHELL |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASAL DARTT IMPLANT - 40M X 4M |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-04-22 |
| Catalog Number | 84008 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355D-7 US 19355 D-79 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |