MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PYRAMESH TITANIUM MESH; MESH, SURGICAL, METAL

Model Number MSB_UNK_HARDWARE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Depression (2361); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Other- one of the patients, an elderly osteoporotic female, lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity.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.(ime/annex e) no code available- lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity (annex g) component: appropriate term/code not available.Product identifier is unknown, hence 510k# is not available.Annex f: appropriate term/code not available.If information is provided in the future, a supplemental report will be issued.

Event Description

David p.Rouben.¿the mast tlif lumbar spinal fusion technique: a twenty-four month retrospective analysis for the treatment of symptomatic segmental lumbar disc disease-ssldd¿.Summary: there were 114 consecutively studied patients between january 2002 and december 2004.There were 57 males and 57 females.Ages ranged from 17 to 73 years of age but averaged 45 years old.All patients underwent general anesthesia and positioned prone on the jackson table.Incisions were made only through the skin and subcutaneous layers directly over the involved pedicles on either side of the midline.A single oec c-arm 9800 was used to identify the appropriate segment and its anatomical structures.The medtronic ® cd horizon® sextant® percutaneous rod system was utilized to access, drill, tap, and insert multi-axial cannulated pedicle screws and connecting rods.The 26 mm.Medtronic ® metrx® minimal exposure tubular retraction system was used via a muscle fiber separation technique to minimize permanent injury to the muscle tissue.The predominant symptomatic sides were access at the level of the intrapedicular space at a 25¿30-degree angle from the vertical plane of the posterior process.Resection of the entire facet and ligamentum flavum from the postero-lateral canal space and the intrapedicular space was performed.The annulus and nucleus were resected through the intrapedicular space.Intra-discal distraction was accomplished by the medtronic ® scissor jack¿ distractor.The endplates were debrided of their cartilage surfaces.Local bone was harvested during access and decompression was morselized and placed in the anterior third of the disc, followed by medtronic® infuse® bmp-2, followed by a cage filled with medtronic® infuse® bmp-2 and autologous bone.Pedicle screws was locked in compression.Wounds were closed in layers with the skin sealed with glue.Patients were discharged when they were comfortable on analgesics by mouth and participated in a supervised and structured rehabilitation program beginning seven days after surgery.Patients returned for follow-up at 4, 8, and 12-week post-op, followed by 6, 12, 15, 18, and 24-month intervals.A personal interview with each patient occurred at each return follow up visit to discern the status of each of the data points being tracked for this study.Lumbar segmental lordosis was measured by drawing a perpendicular from the top of the superior fused vertebrae to the bottom of the inferior vertebrae.In the case of s1, the perpendicular was drawn along the superior endplate of s1.The disc height was measured from the inferior posterior edge of the superior vertebrae to the superior posterior edge of the inferior vertebrae.The extent of spondylolisthesis reduction of an individual segment was made by measuring the percentage of anterior slip that no longer existed after surgery.Three different interbody implants supplied by medtronic® were used in the study.43 pyramesh® surgical titanium mesh oval implants, 63 boomerang shaped vertestack anatomic peek¿ spacer implants, and 8 hydros orb® resorbable material ring implants were used.Complications were listed and compiled as a matter of record for short term events (less than six months) and for long term events (greater than six months).There were no post operative infections.No patients to date have undergone surgery for adjacent level symptomatic disease.Reported events: 1.One of the patients, an elderly osteoporotic female, lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity.2.2.6% of the patients were treated for piriformis syndrome or noted radiographic evidence of a misdirected pedicle screw.3.1.8% of the patients were hospitalized for post operative depression.4.0.8% of the patients were either hospitalized post operatively for a cardiac event or loss of fixation, or symptomatic leg pain from a misdirected pedicle screw necessitating re-operative surgery.5.20% of the patients complained of unresolved back pain necessitating chronic narcotic use.6.3.5% of our patients¿ necessitated removal of their pedicle implants for persistent focal back pain.7.1.8% of the patients complained of unresolved preoperative leg pain or never returned to work.8.0.8% of the patients experienced new onset leg pain that persisted or experienced a pseudo-arthosis of the fused segment.

Manufacturer Narrative

Product information is unavailable.Hence, 510k is unknown.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

Correction: d1, d2.Reason for using unknown in d1, d2: three different interbody implants were used in the patients i.E., pyramesh® surgical titanium mesh oval implants, boomerang shaped vertestack anatomic peek¿ spacer implants, and hydrosorb® resorbable material ring implants.We don¿t have enough information to associate the above-mentioned products individually with the adverse event.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

Correction: b1, b2, d1, d2, h6 (ime/annex e, fdd/annex a), imf, img.B.2: one of the patients, an elderly osteoporotic female, lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity.B.2: 1.8% of the patients i.E., two patients were hospitalized for post operative depression.B.2: 0.8% of the patients i.E., one patient was either hospitalized post operatively for a cardiac event or loss of fixation, or symptomatic leg pain from a misdirected pedicle screw necessitating re-operative surgery.B.2: 20% of the patients i.E., 23 patients complained of unresolved back pain necessitating chronic narcotic use.B.2: 3.5% of the patients i.E., 4 patients necessitated removal of their pedicle implants for persistent focal back pain.H6: (ime/annex e) no code available for lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity annex g component: appropriate term/code not available.Annex f health impact: appropriate term/code not available.H6: (ime/annex e) no code available for cardiac event or loss of fixation.H6: (ime/annex e) no code available- lost complete stabilization and reduction when her pedicle fixation failed to maintain boney continuity.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: PYRAMESH TITANIUM MESH
• Type of Device: MESH, SURGICAL, METAL
• 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: 14218719
• MDR Text Key: 290265375
• Report Number: 1030489-2022-00413
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_HARDWARE
• Device Catalogue Number: MSB_UNK_HARDWARE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male