MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-21 for UNKNOWN DYNESYS SPINE IMPLANT N/A manufactured by Zimmer Gmbh.
[145688826]
The manufacturer did not receive x-rays, or other source documents for review. As no lot number was provided, the device history records could not be reviewed. An e-mail requesting the following additional information was sent on may 17, 2019 to the appropriate representatives: please confirm the notification date. Any device identification(s) and control number(s) used (ref; lot)? Clarification regarding the nature and details of the complaint? Were there dynesys implants already implanted before the revision surgery in 2012? What was the reason for the revision surgery in 2012? What kind of issues is the patient facing with now (spinal stenosis)? Exact event date (first symptoms)? Implant date? In which hospital was the procedure performed and who was the surgeon? Were the medical documents provided to you by the patient? All available x-rays during time in- vivo with printed date? Patient dob, weight, height, bmi and all relevant history? Is there a revision surgery planned for the patient? ? I noticed the patient is looking for surgeons who could perform his surgery? Were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy)? Was the surgical technique for the product upon implantation utilized? A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145688827]
A patient reported the following: it was reported that the patient complains about unknown problems after implantation of an unknown dynesys spine implant in 2012. Note: additional information has been requested and is currently not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2019-00318 |
| MDR Report Key | 8629338 |
| Report Source | CONSUMER |
| Date Received | 2019-05-21 |
| Date of Report | 2019-10-09 |
| Date Mfgr Received | 2019-10-02 |
| Date Added to Maude | 2019-05-21 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DYNESYS SPINE IMPLANT |
| Generic Name | UNKNOWN |
| Product Code | NQP |
| Date Received | 2019-05-21 |
| Model Number | N/A |
| Catalog Number | UNKNOWN DYNESYS SPINE IMPLANT |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |