MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-08-02 for INTRABEAM NEEDLE APPLICATOR 304534-3001-200 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[51000304]
Narrative: the manufacturer confirmed that there was no malfunction of the intrabeam system or the intrabeam guiding sleeve. The hcp confirmed that the root cause was applying to much pressure on the guiding sleeve when inserting it into the pedicle and vertebra. The guiding sleeve is not intended to remain in the body and biocompability is tested for 24 hours. The user manual g-30-1723-en, version 8, advises on page 32 "ensure that all components of the "intrabeam needle applicator" set have been completely removed from the body. ". Standard external beam radiation therapy is an alternative treatment and can usually be used as follow-up treatment. The hcp made the decision to cement the guiding sleeve in the pedicle like a pedicle screw.
Patient Sequence No: 1, Text Type: N, H10
[51000305]
For an intraoperative radiotherapy (iort) during kyphoplasty surgery, the intrabeam system is used together with an intrabeam needle applicator in order to treat interstitial irradiation of tumors. The healthcare professional (hcp) reported that the intrabeam female guiding sleeve, which is a component of the intrabeam needle applicator set, was placed into the pedicle and vertebra with too much pressure causing the sleeve to move completely into the pedicle and vertebra. As a consequence, iort could not be delivered during the planned kyphoplasty surgery with vertebroplasty. The hcp could not remove the penetrated intrabeam female guiding sleeve and he decided to cement the guiding sleeve in the pedicle like a pedicle screw, which was done during the respective standard cementation procedure. The hcp confirmed that the penetration of the guiding sleeve and its cementation did not cause any harm to the patient. The required radiation dose was delivered afterwards via external beam radiotherapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00011 |
| MDR Report Key | 5842177 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-02 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-08-02 |
| 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 | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRABEAM NEEDLE APPLICATOR |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2016-08-02 |
| Model Number | NA |
| Catalog Number | 304534-3001-200 |
| Lot Number | 15295 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-02 |