MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown depuy spine skyline screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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 ((b)(6)) for patients who underwent anterior-only multilevel cervical 4 decompression and instrumented fusion for degenerative disease.Based on the retrospective data review of historically treated patients, the following have been identified as the reported complications: complications: 13 patients had pseudoarthrosis.4 patients had cervical haematoma.3 patients had c5-palsy with recovery.1 patient had csf leakage.1 patient had severe postoperative delirium.1 patient had keloid scarring.1 patient had symptomatic screw loosening with retraction.5 patients had chronic dysphagia.2 patients had recurrent laryngeal nerve (rln) palsy with persistent hoarseness.3 patients had rln palsy with recovery.Reoperations: 10 patients had posterior instrumented spinal fusion (psf) for non-union with/without.Symptomatic adjacent segment disease (sasd).6 patients had anterior/posterior extension of fusion for asd.4 patients had anterior hematoma evacuation.1 patient had re acdf procedure for nonunion.1 patient had re acdf procedure for asd.1 patient had repair of csf-leak.1 patient had early redecompression c4-6 for sever c5-palsy.1 patient changed loosened anterior screw of c3.Revisions: 8 patients had early revisions (<1 month).10 patients had late revisions (>1 month).Symptomatic adjacent segment disease: 51 patients had symptomatic adjacent segment disease-any level.51 patients had asd at upper instrumented level (uiv).24 patients had asd at lower instrumented level (liv).This report is for depuy spine skyline screw: it captures the reported reoperation - changed loosened anterior screw of c3.This is report 4 of 10 for (b)(4).Additional devices are reported under related (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 11565581
• MDR Text Key: 254868519
• Report Number: 1526439-2021-00542
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• 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