MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned for investigation.Based on the information available, it has been determined that no corrective and 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 france as follows: this report is being filed after the review of the following journal article: rabboa, f.A.Et al.(2020), long-term complications of minimally open anterolateral interbody fusion for l5-s1, neurochirurgie, vol.66, pages 85-90 (france).The aim of this study was to report the long-term complications and fusion rates of minimally open (mini-open) anterolateral interbody fusion at the l5-s1 level.A total of 17 patients underwent mini-open anterolateral interbody fusion at l5-s1.There were 8 males and 9 females with a mean age was 64.5 years.All patients underwent a complementary posterior procedure that included fixation.Implants used were cougar cages.The mean follow-up period was 28.3 months.The following complications were reported: a (b)(6) year-old female patient had compressive hematoma that evolved to abscess.Fusion was achieved.A (b)(6) year-old male patient had proximal junction kyphosis (pjk).Fusion was not achieved.A (b)(6) year-old male patient had pain.Fusion was not achieved.A (b)(6) year-old patient had cage displacement.Fusion was achieved.A (b)(6) year-old female patient had anemia and delirium.Fusion was achieved.A (b)(6) year-old female patient had psoas paresis.Fusion was achieved.A (b)(6) year-old male patient had pulmonary atelectasis without infection.Fusion was not achieved.A (b)(6) year-old male patient had ileus complications.Fusion was achieved.A (b)(6) year-old male patient had psoas paresis.Fusion was achieved.A (b)(6) year-old female patient had anemia and psoas paresis.Fusion was achieved.This report is for an unknown synthes cougar cage.This report is for (1) unknown cage/spacer.This report is 2 of 7 (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11837402
• MDR Text Key: 264718638
• Report Number: 1526439-2021-00953
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention