MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Migration (4003)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Neck Pain (2433); Post Operative Wound Infection (2446); Decreased Sensitivity (2683)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression, fusion, rigid stabilization, and motion preserving stabilization.Failed spinal decompression, fusion, rigid stabilization, and motion preserving stabilization has been identified as per spine tango registry report experienced by the following with corresponding intervention: 19 patients had general complications - intraoperative: anaesthesiological (4), cardiovascular (4), pulmonary (1), thromboembolism (1), other (4), not documented (5).149 patients had general complications - postoperative surgical before discharge: cardiovascular (15), pulmonary (30), cerebral (8), kidney / urinary (25), liver / gi (16), thromboembolism (6), death (7), other (30), not documented (12).109 patients had surgical complications - intraoperative adverse events: nerve root damage (4), dural lesion (85), vascular injury (3), fracture vertebral structures (1), other (12), not documented (4).164 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (7), other hematoma (13), radiculopathy (8), csf leak / pseudomeningocele (11), motor dysfunction (25), sensory dysfunction (16), bowel / bladder dysfunction (7), wound infection superficial (16), wound infection deep (14), implant malposition (15), implant failure (2), other (18), not documented (12).93 patients had reoperations at any level due to adjacent segment pathology (17), failure to reach therapeutic goals (9), hardware removal (17), implant failure (18), implant malposition (2), instability (11), neurocompression (7), non-union (9), other (4), postoperative infection deep (2), sagittal imbalance (2), unknown (53); 38 patients had reoperations at the same level due to adjacent segment pathology (3), failure to reach therapeutic goals (3), hardware removal (5), implant failure (7), implant malposition (1), instability (2), neurocompression (3), non-union (4), other (1), postoperative infection deep (1), unknown (23).This is for depuy spine expedium and viper pedicle screw systems.This report is for one (1) unknown mono/polyaxial screw.This is report 4 of 6 for (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 12219880
• MDR Text Key: 266308515
• Report Number: 1526439-2021-01509
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2021
• 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