MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-01-18 for TIMESH 853010WM manufactured by Warsaw Orthopedics.
[65026180]
Devices of multiple part/lot numbers were implanted during the procedure including: part: 853010wm / lot: 0463760w (x1) part: 853010wm/ lot: 0463700w (x1); part: 853010wm/ lot: 0438447w (x1); part: 853010wm/ lot: 0106859w (x1); part: 853-467/ lot: 0497212w (x7); part: 853-469 / lot: 0489775w (x9). Although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes. (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
[65026181]
It was reported that on (b)(6) 2016, patient underwent a surgery due to ossification of posterior longitudinal ligament and stenosis of spinal canal. Post-op, patient had neck pain, limb weakness and 0 lower limb muscle strength. Due to which the patient underwent a revision surgery on (b)(6) 2016 in which posterior cervical decompression with vertex internal fixation was performed. The products came in contact with the patient. Patient was also reported with bleeding "after the surgery. " after revision surgery patient had neck pain relief but 0 lower limb muscle strength.
Patient Sequence No: 1, Text Type: D, B5
[98439704]
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 | 1030489-2017-00124 |
| MDR Report Key | 6259504 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-18 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2016-12-23 |
| Date Added to Maude | 2017-01-18 |
| 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 | TIMESH |
| Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| Product Code | NQW |
| Date Received | 2017-01-18 |
| Model Number | NA |
| Catalog Number | 853010WM |
| Lot Number | 0463760W |
| 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 | 2017-01-18 |