MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM VERSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Failure of Implant (1924); Nerve Damage (1979); Decreased Sensitivity (2683); Unspecified Nervous System Problem (4426); Vertebral Fracture (4520); Unspecified Tissue Injury (4559)

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.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

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) "spine tango implant report ¿ expedium verse all".A total of 323 patients (333 procedures; 137 male and 196 female; mean age of 65.4 years) who were operated with depuy synthes expedium verse implants from september 17, 2020 to june 3, 2022.It was not specified in the spine tango registry report which of the devices mentioned have caused the adverse events.It was also not specified in which country the adverse events have occurred.Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: general complications - postoperative: 1 patient had cerebral complication.1 patient had kidney/urinary complication.1 patients had other complication.Surgical complications - intraoperative: 2 patients had nerve root damage.1 patient had spinal cord damage.26 patients had dural lesion.2 patients had fracture vertebral structures.Surgical complications - postoperative: 2 patients had other hematoma.1 patient had csf leak/pseudomeningocele, 1 patient had sensory dysfunction.1 patient had bowel/bladder dysfunction.1 patient had implant failure.Postoperative complications: 1 patient had other complications.Reoperations: 1 patient had reoperation at any level due to instability.This is for unknown depuy spine expedium verse.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM VERSE
• 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 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15616093
• MDR Text Key: 301848717
• Report Number: 1526439-2022-01807
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• 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
• Patient Outcome(s): Required Intervention