MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-18 for UNKNOWN ROD UNK ? SPINAL IMPLANT manufactured by Depuy Synthes Spine.
[57780882]
Additional narrative: a complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[57780883]
Maude report received from fda: mw5064317. Reporter called on behalf of daughter who had an implant for the first time on (b)(6) 2013 for sclerosis. Two rods were implanted and pt was hospitalised for 9 days. Shortly after she got home, she started screaming in pain. When the doctor was called, he told patient to go to sleep and never to call him again at 2am. Three days later, it was discovered that the rods were broken. The doctor took off the broken rods and replaced with two other rods and additional screws were put in. Surgery took close to 10 hours and after the surgery, she had face swelling and the anesthesia altered her thinking. She was later taken for a 2 week check up and doctor said she should find another doctor. The only doctor she found did another surgery and implanted 4 rods and fused her back. She came out of surgery with swollen chin, blisters inside her mouth and on her tongue. She couldn't eat or drink. Even till date, if she smells any chemical it burns her throat. The third set of rods are broken again and no doctor will see her. She read on the internet that some representatives were selling defective rods. At the moment, patient's feet are swollen, she has pressure in her back and chest, blood clot in her lungs and a lot of back pain. The doctors now say they have to break her back because her back was fused by the previous doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2016-10783 |
| MDR Report Key | 6038008 |
| Report Source | CONSUMER |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-23 |
| Report Date | 2016-08-22 |
| Date Reported to FDA | 2016-08-22 |
| Date Reported to Mfgr | 2016-09-23 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-10-18 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ROD |
| Generic Name | UNKNOWN |
| Product Code | JDN |
| Date Received | 2016-10-18 |
| Catalog Number | UNK ? SPINAL IMPLANT |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-10-18 |