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 2016-12-09 for PYRAMESH IMPLANT SYSTEM G905H320 manufactured by Warsaw Orthopedics.
[61852480]
This product is not approved for sale in us but a similar device with catalog number 905-320 and 510k number k890601 is approved for sale in us. (b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[61852481]
It was reported that on (b)(6) 2016, patient underwent c3/5 anterior cervical diskectomy and fusion (acdf) and posterior spinal fusion. On an unknown date, post-op, one screw in the right side of caudal portion backed out. In addition, the spinal cage migrated. The dura mater was compressed by the cage and numbness of the hand had worsened (on an unknown date), thereafter the patient underwent x-ray on (b)(6) 2016 which revealed that the implants had dislocated. Therefore, a revision surgery was performed on (b)(6) 2016. In which all the implants were replaced. The patient underwent spinal fusion due to trauma. The patient had instability in posterior components including facet joint and had poor bone. Plate couldn't be well seated on the bone due to its unfavorable shape. All the implants were removed. There was prolongation of hospitalization due to the revision surgery and there was a delay of more than 60 minutes in overall procedure in the revision surgery. Doctor? S comment: "it couldn't be determined which occurred first back-out of screw or cage migration. The rock screw may have not been steadily tightened. "
Patient Sequence No: 1, Text Type: D, B5
[62725884]
Image review: post-op, pre-revision x-rays provided after c3-5 anterior stabilization of traumatic fracture with c4 corpectomy. These show failure of the construct with cage migration. Per comments structures were disrupted posteriorly and some difficulty was encountered with plate placement at initial surgery. This suggest that 360 degree construct would have been appropriate initially.
Patient Sequence No: 1, Text Type: N, H10
[99248100]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2016-03386 |
| MDR Report Key | 6157487 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-16 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-12-09 |
| 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 | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYRAMESH IMPLANT SYSTEM |
| Generic Name | MESH, METAL |
| Product Code | EZX |
| Date Received | 2016-12-09 |
| Model Number | NA |
| Catalog Number | G905H320 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-09 |