MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PYRAMESH IMPLANT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CG_PYRMH

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

A2: please note that the age is based off average age of patient involved in this event a3: please note that the gender is based off as per the majority of patients.B2: other outcome attributed to adverse event: permanent impairment due to dysphagia in 12 patients.B3.Please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.D4, g4: product identifiers are unknown.D section 6a: implant date unknown.G3: product identifiers are unknown.H6: 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.Tangyiheng chen, yujie wang, hong zhou, md1, cheng lin, xuefeng li, huilin yang, yijie liu and weimin jiang." comparison of anterior cervical discectomy and fusion versus anterior cervical corpectomy and fusion in the treatment of localized ossification of the posterior longitudinal ligament" journal of orthopaedic surgery.31(1) 1¿12, doi:10.1177/10225536231167704 digital sharing of the article would be in violation of copyright permission.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: the retrospective study was conducted to compare the efficacy of anterior cervical discectomy and fusion (acdf) and anterior cervical corpectomy and fusion (accf) for localized ossification of the posterior longitudinal ligament (opll) by evaluating clinical and radiologic outcomes.Reported events: the acdf and accf techniques were performed via a standard cervical anterior approach.After discectomy or corpectomy, titanium mesh cages (pyramesh, medtronic inc, usa) with anterior plates (venture, medtronic inc, usa) were used for accf and zero-profile anchored spacer (roi-c, ldr, troyes, france) with clips for acdf.This retrospective and comparative clinical study was from january 2018 to january 2021.151 consecutive patients were selected based on the timing of presentation who were without lost follow-up to assess the effects of treatment for one or two levels localized opll.74 patients were involved in the accf group.Perioperative parameters, such as blood loss, operation time and complications, were recorded.52 patients had preoperative diagnosis of cervical spondylotic radiculopathy (csr) with cervical spondylotic myelopathy (csm) and remaining 22 patients had cervical spondylotic radiculopathy without cervical spondylotic myelopathy.In the accf group, themean operation time for one level was 131.9 ± 24.5 min.The corresponding volume of blood loss was 129.0 ± 22.5.The operation times for the two levels was 176.2 ± 23.1 min, respectively.The corresponding blood loss was 162.5 ± 26.6ml.30 patients (40.5%) in the accf group complained of dysphagia.One month postoperatively, dysphagia disappeared in 12 patients.Finally, 12 patients had no apparent relief.The subsidence rates of implants was 28.4% (21 patients) in the accf group.The adjacent segment degeneration (asd) of the accf group was 4.1% (3 patients).Cerebrospinal fluid leak (csfl) occurred in ten (13.5%) accf patients.

• Brand Name: PYRAMESH IMPLANT SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 17296490
• MDR Text Key: 319005770
• Report Number: 1030489-2023-00498
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CG_PYRMH
• Device Catalogue Number: MSB_UNK_CG_PYRMH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• 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