MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 5.0X35; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Planned revision: posterior spinal fusion, (b)(6).Surgeon reported that all of the screws has broken inside the pedicle.An x-ray image is to be sent to jnj representative.More to follow as and when surgeon provides.(b)(6).

• Brand Name: 5.5 EXP VERSE FEN SCR 5.0X35
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7532976
• Report Number: 1526439-2018-50478
• Device Sequence Number: 134522
• Product Code: MNI
• UDI-Device Identifier: 10705034403274
• UDI-Public: (01)10705034403274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723535
• Device Catalogue Number: 199723535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/22/2018
• 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: Required Intervention