MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-07 for SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MM SN2027-0-20055 manufactured by Zimmer Spine.
[116215329]
Udi number: ni. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116215350]
It was reported that a vertebral body fractured during surgery while installing two spinal implant devices. No further information has been provided. This is report two of two for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003853072-2018-00059 |
| MDR Report Key | 7756375 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-07 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2017-12-31 |
| Date Added to Maude | 2018-08-07 |
| 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 | MRS. TERESA GEORGE |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER SPINE |
| Manufacturer Street | 23 PARVIS DES CHARTRONS CITE MONDIALE |
| Manufacturer City | BORDEAUX, CEDEX 33080 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MM |
| Generic Name | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
| Product Code | OWI |
| Date Received | 2018-08-07 |
| Model Number | NA |
| Catalog Number | SN2027-0-20055 |
| Lot Number | W59827 |
| 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 | 23 PARVIS DES CHARTRONS CITE MONDIALE BORDEAUX, CEDEX 33080 FR 33080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |