MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-13 for CD HORIZON SPINAL SYSTEM SEE H10 manufactured by Warsaw Orthopedics.
[183373562]
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. The following products were used in the surgery: product id: 1475501030, 510k: k113174, udi: (b)(4). Product id: 9392513, 510k: k094025, udi: (b)(4). Product id: 54840006540, 510k: k091974, udi: (b)(4). Product id: 5440030, 510k: k102555, udi: (b)(4). Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183373563]
It was reported that patient's sibling that his/her sister has an allergy to nickel. 10 years ago she (the patient) broke her arm. She had to have a rod inserted with metal screws. Her arm became infected. Metal screws had to be removed and replaced with plastic screws. On (b)(6) 2019 she had spinal surgery (fusion spine posterior). She was hospitalized for over 3 months. Her incision got infected and she had numerous antibiotics. Today she is in very critical condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00302 |
| MDR Report Key | 9827828 |
| Report Source | CONSUMER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-10-10 |
| Date Mfgr Received | 2020-02-15 |
| Date Added to Maude | 2020-03-13 |
| 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 | STACIE ZIEMBA |
| 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 | CD HORIZON SPINAL SYSTEM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Product Code | KWP |
| Date Received | 2020-03-13 |
| Model Number | NA |
| Catalog Number | SEE H10 |
| Lot Number | SEE H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-13 |