MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK CAGE/SPACER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problem Unspecified Nervous System Problem (4426)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma - 510k: this report is for an unknown unk cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: zhou, t.Et.Al (2023), percutaneous transforaminal endoscopic surgery combined with mini-incision olif and anterolateral screws rod fixation vs.Mis-tlif for surgical treatment of single-level lumbar spondylolisthesis, frontiers in surgery, vol.X (xx) pages 1-11 (china).The aim of this single center retrospective study was to evaluate the feasibility, efficacy, and safety of this method compared with minimally invasive surgery-transforaminal lumbar interbody fusion (mis-tlif).Between july 2016 to may 2018, 65 patients (group a 12 females and 19 males with mean age of 60 ± 8 years; group b 21 females and 13 males with mean age of 61 ± 7 years) of single lumbar spondylolisthesis from l1 to l4 with neurologic symptoms were treated using ptes combined with mini incision olif and anterolateral screws rod fixation (31 cases, group a) or mis-tlif (34 cases, group b) in this study.This study only includes olif25 from l2¿5 for the treatment of l2¿4 spondylolisthesis because olif51 of l5/s1 for l5 spondylolisthesis has different approach and cage.The olif cage (medtronic, inc., minneapolis, mn, united states) and the pedicle screws (medtronic, inc., minneapolis, mn, united states) were used in group a (ptes + mini-incision olif and anterolateral screws rod fixation) while pedicle screws, expandable tubular retractor and cage (depuy, inc., warsaw, in, united states) for group b (mis-tlif).The median clinical follow-up was unknown.The following complications were reported as follows.Group b (mis-tlif): 2 patients encountered dural tear and cerebrospinal fluid leakage from drain without neurologic symptoms.Their wound healed after the drainage tube was removed 7 days postoperatively; a 44-year-old female patient with 3d ct reconstruction showed the screws, cage, and neurologic decompression in mis-tlif.A copy of the literature article is being submitted with this medwatch.This report involves one unk cage/spacer.This is report 2 of 4 for (b)(4).

• Brand Name: UNK CAGE/SPACER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16583397
• MDR Text Key: 311685767
• Report Number: 1526439-2023-00553
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: PEDICLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female