D
Patient 1
IT WAS REPORTED THAT; RODS BROKEN IMPLANTED INTO MY SPINE. BOTH (2) WILL NEED TO BE REPLACED.
MAUDE MDR 5199316
- MDR report key
- 5199316
- Report number
- 0009617544-2015-00470
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-09-16
- Date received
- 2015-11-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTA MARROW
- Address
- 2 PEARL COURT ALLENDALE NJ 07401 US
- Phone
- 201-201-2017
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN_SPINE_PRODUCT | UNKNOWN SPINE PRODUCT | STRYKER SPINE-FRANCE | JDN | UNK_SPN | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-03 | 0 | 1. R |
Event Narratives#
N
Patient 1
METHOD: NO METHODS PERFORMED BECAUSE DEVICE WAS NO PROPERLY IDENTIFIED AND NOT RETURNED. RESULTS: NO RESULTS AVAILABLE BECAUSE NO METHODS WERE PERFORMED. CONCLUSION: THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE AND/OR INSUFFICIENT INFORMATION WERE PROVIDED FOR REVIEW.
D
Patient 1
IT WAS REPORTED THAT; RODS BROKEN IMPLANTED INTO MY SPINE. BOTH (2) WILL NEED TO BE REPLACED.
N
Patient 1
METHOD: DEVICE HISTORY REVIEW. DEVICE NOT RETURNED. RESULTS: DEVICE HISTORY AND COMPLAINT HISTORY COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NO PROPERLY IDENTIFIED. IMAGES PROVIDED FOR REVIEW SHOW TWO FRACTURED RODS. NO CAT/LOT NUMBERS CAN BE IDENTIFIED FROM THE IMAGES PROVIDED. THE PATIENT HAD SEVERAL RISK FACTORS FOR THE NON-UNION, INCLUDING A HISTORY OF SMOKING, MARIJUANA USE, HEPATITIS C AND DIRECT TRAUMA TO HIS SURGERY SITE. SPINAL FUSION HARDWARE IS DESIGNED TO HOLD THE FRACTURE TOGETHER AS IT HEALS. IT SERVES AS A TEMPORARY FIXATION DEVICE. HOWEVER, IF UNION, OR FUSION, DOES NOT TAKE PLACE, IT CAN RESULT IN THE HARDWARE BREAKING. CONCLUSION: THE EVENT WAS CONFIRMED. PER CLINICAL CONSULTANT'S MEDICAL REVIEW; THE NON-UNION CAUSED THE FRACTURE OF THE RODS.
D
Patient 1
IT WAS REPORTED THAT; RODS BROKEN IMPLANTED INTO MY SPINE. BOTH (2) WILL NEED TO BE REPLACED.