MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EAGLE+ ACP, 2 LEVEL, 36MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	183612036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anxiety (2328); Distress (2329); No Code Available (3191)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Maude report number mw-5075745.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient was implanted with depuy spine devices after being involved in a automobile accident.Postoperatively, approximately 1.5 years later, the patient presented with an unknown issue involving one of the devices.Maude report number mw-5075745.Devices involved: eagle plate: 1836-12-036; gelfoam themostatis; acromed bengal court cage; acromed bengal court cage: 1773-06-032; screw: 1836-50-014.

• Brand Name: EAGLE+ ACP, 2 LEVEL, 36MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7459250
• Report Number: 1526439-2018-50403
• Device Sequence Number: 1093121
• Product Code: KWQ
• UDI-Device Identifier: 10705034095448
• UDI-Public: (01)10705034095448
• Combination Product (Y/N): N
• PMA/510(K) Number: K070994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 183612036
• Device Catalogue Number: 183612036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization