MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-04-21 for CLIP PISTON MVP 1006 711 manufactured by Heinz Kurz Gmbh Medizintechnik.
[2006366]
On (b)(6) 2011, health professionals at (b)(6), discovered a discrepancy in implant size labeling on the package of the clip piston mvp titanium implant. The size was properly labeled as dia. 0. 4 x 5. 75 mm on the front outside of the package, the pt/hospital labels on the inside and on the primary package containing the sterile implant. However, on the tear flap on the side, the size was indicated as dia. 0. 4 x 6. 5 mm.
Patient Sequence No: 1, Text Type: D, B5
[9008842]
Potential risk: when selecting the implant length for a surgical procedure on the basis of the 6. 5 mm size indicated on the flap tear, the implant may not reach far enough into the perilymphatic space to achieve optimal sound transfer. The resulting lack of hearing gain may make revision surgery necessary. Manufacturer comment: the clip piston mvp is designed to connect the malleus handle with the inner ear. The ball joint in the shaft makes the implant uniquely bendable to facilitate adjustment to the pt's anatomical situation. It is expected that the surgeon would immediately recognize that the 0. 75 mm shorter implant (5. 75mm instead of 6. 5 mm) does not reach the perilymphatic space. Therefore, the risk that such an implant would actually be surgically placed, appears to be very low. Recall: nevertheless, the mfr has decided to initiate a complete recall of the 32 devices produced with lot 2091306. According to our records, only eight (8) of these devices were sold in the usa. The recall procedures commence today,(b)(4) 2011 and are expected to be completed by (b)(4) 2011. A final report will be submitted approx (b)(6) month(s) later. Capa: to prevent the occurrence of such mislabeling in the future, kurz has initiated corrective actions affecting the package labels and related verification procedures regarding all of their middle ear implants.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010617-2011-00001 |
| MDR Report Key | 2093872 |
| Report Source | 01,08 |
| Date Received | 2011-04-21 |
| Date Mfgr Received | 2011-04-14 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2012-06-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. UWE STEINHARDT, CTO |
| Manufacturer Street | TUBINGER STR. 3 |
| Manufacturer City | DUSSLINGEN 72144 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72144 |
| Manufacturer Phone | 07291790 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIP PISTON MVP |
| Generic Name | TOTAL OSSICULAR PROSTHESIS |
| Product Code | ETA |
| Date Received | 2011-04-21 |
| Model Number | 1006 711 |
| Catalog Number | 1006 711 |
| Lot Number | 2091306 |
| Device Expiration Date | 2013-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEINZ KURZ GMBH MEDIZINTECHNIK |
| Manufacturer Address | TUBINGER STR. 3 DUSSLINGEN 72144 GM 72144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-21 |