MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/24/2011

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Event Description

On (b)(6) 2009: the patient came for a follow-up visit and diagnosed with(i) sprain/strain lumbosacral(joint)(ligament) (ii) lower back pain (iii) degenerative lumbar disc with angular tear l5-s1.On (b)(6) 2009: the patient underwent mri.Impressions: degenerative lumbar disc with angular tear l5-s1.On (b)(6) 2011: the patient was pre-operative diagnosed with i) herniated disc l5-s1 ii) internal disc disruption iii) lumbar instability causing pain iv) positive discogram l5-s1 and underwent l5-s1 anterior lumbar discectomy with interbody fusion using peek cages and bmp.As per op notes, ¿i made an incision in the anterior longitudinal ligament anterior annulus and removed disc material in bloc from the disc interspace.I continued the discectomy back to the posterior longitudinal ligament removing most of the disc in the interspace.After this was completed i then confirmed that we had gone posteriorly to the appropriate depth and put in a 16 mm dual tube drill guide.This drill guide and reamed were used to remove the endplate to put in the two 16 mm cages on either side of midline.After reaming to a depth of 29 mm i confirmed that this was 3 mm from the posterior edge of the annulus.I reamed on both sides of midline and then put in a 16x23 mm peek cage filled bone morphogenic protein and with allograft.These were placed slightly recessed in the disc interspace.Once this was i pulled out the dual tube drill guide and adjusted the peek cage so that they were parallel.I then covered the anterior portion of the tapered cages with gelfoam.Another dr.Then proceeded to close the approach as dictated in his operative report.¿.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 9646319
• MDR Text Key: 187369254
• Report Number: 1030489-2020-00114
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2013
• Device Catalogue Number: 7510200
• Device Lot Number: M110911AAF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 57 KG