MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-30 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc.
[187369254]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187369255]
It was reported that patient underwent two surgeries ((b)(6) 2011 and (b)(6) 2011) and experienced post-op injury. (b)(6) 2011: the patient underwent anterior exposure of l5-s1 interspace for disc excision and fusion. The findings were: patient was brought to the operating room, placed supine on the operating table. General endotracheal anesthesia was induced. He was then prepped and draped in the usual sterile manner. The operation was begun through a left paramedian incision. Dissection was carried down to the external oblique aponeurosis. The external oblique aponeurosis was then opened, and the rectus muscle was reflected medially. The retroperitoneum was then entered laterally. Using a combination of blunt and sharp dissection the peritoneal cavity was mobilized medially exposing first the external iliac artery and common iliac artery and subsequently the common iliac vein. The l5-s1 disc space was then exposed. The middle sacral artery' was identified and this was cauterized. Dr. Pencek then entered the field and assisted with final exposure by placing the endoring. Once adequate exposure was obtained dr. Pencek began the disc excision and fusion. Please see his dictation regarding this. I did assist him with this part of the procedure. Once the disc excision and fusion was completed the retroperitoneal was inspected and there appeared to be no bleeding from the great vessels. The peritoneal cavity was then allowed to return to its normal anatomic position. The retroperitoneum was examined and the transversalis fascia did not appear adequate to be closed. We therefore decided just to close the external oblique aponeurosis. This was done with interrupted #1 pds sutures. The wound was then irrigated and then closed in layers with 2-0 and 3-0 vicryl sutures. The skin was closed with a running subcuticular suture and dermabond. A sterile dressing was applied. The patient tolerated the procedure well and there were no complications. Estimated blood loss was 100. Needle and sponge count was correct. Specimens? None. The patient was taken to recovery in stable condition with strong palpable left pedal pulses. (b)(6) 2011: the patient underwent ct lumbar spine without contrast. The findings were: there is no fracture or bone destruction. Posterior fixation screws are now identified at the l5 and s1 levels. The left-sided screw in the upper sacrum projects slightly beyond the anterior cortex of the sacrum. The disc implant at l5-s1 is unchanged. The impression were: posterior fixation screws appearing at the l5 and s1 levels. The left-sided screw in the upper sacrum projects slightly beyond the anterior cortex of the sacrum. (b)(6) 2011: the patient underwent ct lumbar spine without contrast. The findings were: there is no fracture or bone destruction. Posterior fixation screws are now identified at the l5 and s1 levels. The left sided screw in the upper sacrum projects slightly beyond the anterior cortex of the sacrum. The disc implant at l5-s1 is unchanged. The impressions were: posterior fixation screws appearing at the l5 and s1 levels. The left-sided screw in the upper sacrum projects slightly beyond the anterior cortex of the sacrum. (b)(6) 2016: the patient underwent rad/xr lumbar spine. The findings were: screw noted in the body of l4 and l5. These are seen posteriorly. One screw is noted on each side joined by vertical rods on each side. In addition metallic pins noted in the space between l5 and s1. No recent fracture seen. Sacrum is intact. The impression were: posterior screw noted in the body of l4 and l5 with vertical rod on each side. These are postoperative changes. No other significant findings noted. No recent fracture seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00114 |
| MDR Report Key | 9646319 |
| Report Source | CONSUMER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2010-10-28 |
| Date Added to Maude | 2020-01-30 |
| 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 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2020-01-30 |
| Model Number | NA |
| Catalog Number | 7510200 |
| Lot Number | M110911AAF |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |