MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-10-31 for UNIVERSAL CLAMP GENERIC SN2027 UNIVERSAL manufactured by Zimmer Spine.
[20328836]
Same case as: 3003853072-2014-00035. Info received from journal article. Pt underwent surgery then experienced implant-related complications with development of an aseptic soft tissue reaction with granulomas adjacent to the sublaminar polyethylene terephthalate strapsetitanium clamp mechanism of the device 8 months after ais correction surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003853072-2014-00036 |
| MDR Report Key | 4234423 |
| Report Source | 01,08 |
| Date Received | 2014-10-31 |
| Date of Report | 2014-10-05 |
| Date Mfgr Received | 2014-10-05 |
| Date Added to Maude | 2014-11-10 |
| 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 |
| Manufacturer Street | CITE MONDIALE 23 PARVIS DES CHARTRONS |
| Manufacturer City | BORDEAUX 33080 |
| Manufacturer Postal Code | 33080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL CLAMP GENERIC |
| Generic Name | UNIVERSAL CLAMP GENERIC |
| Product Code | OWI |
| Date Received | 2014-10-31 |
| Model Number | SN2027 UNIVERSAL |
| Catalog Number | SN2027 UNIVERSAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | CITE MONDIALE 23 PARVIS DES CHARTRONS BORDEAUX 33080 33080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-31 |