MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-08 for INFIX 1801-503 manufactured by Zimmer Spine.
[16223976]
Same case as mfr id: 2184052-2014-00083, 00081. The pt was undergoing an anterior lumbar interbody fusion surgical procedure from l5-s1 using infix instrumentation. A construct was assembled in the disc space but was not yet locked. A lateral x-ray was taken to confirm position. Lucency was observed between the superior endplate and struts. The implant was removed and attempted again with the same implant with the same outcome. The implant was then removed and replaced with another and was successfully assembled and implanted. This event resulted in a 10 minute delay. There was no pt impact.
Patient Sequence No: 1, Text Type: D, B5
[16383053]
Age - late 40s. Eval of the returned device was consistent with the reported event; manufacturing records reviewed indicated no deviations or anomalies. It is not suspected that the product failed to meet specifications. The most probable root cause is operational context. This is the final report that will be submitted associated with this incident and device. No additional action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2014-00082 |
| MDR Report Key | 3868797 |
| Report Source | 08 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-04-09 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-09 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-07-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFIX |
| Generic Name | ENDPLATE, LARGE, 3 |
| Product Code | JDN |
| Date Received | 2014-05-08 |
| Returned To Mfg | 2014-04-22 |
| Model Number | 1801-503 |
| Catalog Number | 1801-503 |
| Lot Number | 74SN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 7375 BUSH LAKE RD. MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |