MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE CONTROL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number MSB_UNK_CG_CPSTN P

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

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2022

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.A.3a.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B2: conservative treatment.B.3.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.D.4, g.4.Product identifiers are unknown.H.6.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.Zhuang zhang, bo-wen hu, liang wang, hui-liang yang, tao li, li-min liu, xi yang, yue-ming song.Comparison of long-term outcomes between the n-ha/pa66 cage and the peek cage used in transforaminal lumbar interbody fusion for lumbar degenerative disease: a matched-pair case control study.Orthopaedic surgery 2023;15:152¿161.Doi: 10.1111/os.13593 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.

Event Description

Zhuang zhang, bo-wen hu, liang wang, hui-liang yang, tao li, li-min liu, xi yang, yue-ming song.Comparison of long-term outcomes between the n-ha/pa66 cage and the peek cage used in transforaminal lumbar interbody fusion for lumbar degenerative disease: a matched-pair case control study.Orthopaedic surgery 2023;15:152¿161.Doi: 10.1111/os.13593 in this retrospective and matched-pair case control study, 200 patients who underwent tlif from january 2010 to december 2014 with a minimum 7-year follow-up were included.The present study enrolled 200 patients (76 males, 124 females) with an average age of 56.2 years (range 30¿78 years).One hundred patients who used n-ha/pa66 cages were matched with 100 patients who used peek cages for age, sex, diagnosis, and fusion level.Both n-ha/pa66 and peek cages can achieve satisfactory long-term clinical and radiographic outcomes in tlif.However, the n-ha/pa66 group showed significantly larger cage union ratios than the peek group.Therefore, the results indicated that the n-ha/pa66 cage is an ideal alternative material comparable to the peek cage in tlif.The low elastic modulus and radiolucency of peek cages make them extremely popular with spine surgeons.However, the osseointegration capacity of peek cages is relatively poor due to their bioinert property.The inclusion criteria were patients underwent tlif as the primary surgery between january 2010 to december 2014, and no previous surgical intervention at lumbar.All patients were treated by one of four senior spine surgeons after general anesthesia was administered by a skilled anesthesiologist.The patients were not randomized to the type of cage, and the decision to use n-ha/pa66 or peek cages was made by the surgeon.After pedicle screw positioning, tlif was conducted.Harvested local bone was acquired by removing cartilage and fibrous tissue from excised bone, which was then morselized.After filling the cage with morselized bone, residual bone was inserted into the anterior and contralateral disc space, and then the cage was inserted into the interbody space.Finally, the spinal screw rod system was compressed longitudinally, and the cage was confirmed to be located nicely under fluoroscopy.A total of 60 patients were randomly selected to undergo an evaluation to determine the reliability of imaging measurements.One week after one orthopedic surgeon measured the radiographic parameters for every patient, he repeated the measurements in the 60 randomly selected patients to evaluate intra-observer reliability.Another orthopedic surgeon also measured these parameters in the 60 patients to evaluate inter-observer reliability.The intraclass coefficients (iccs) of the intra-observer and inter-observer reliability were 0.877 and 0.892, respectively.The mean duration of follow-up was 95.4 months (range 86¿114 months).No cage migration or breakage occurred in either group at the final follow-up.For the peek group, there was one patient with csf leakage, one patient with wound infection, and one patient with nerve root injury.All cases resolved completely by conservative treatment.See the attached literature article.

• Brand Name: CAPSTONE CONTROL
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 18927972
• MDR Text Key: 337945847
• Report Number: 1030489-2024-00177
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CG_CPSTN P
• Device Catalogue Number: MSB_UNK_CG_CPSTN P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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
• Patient Age: 56 YR
• Patient Sex: Female