MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR M/L SCREW 3.5 DIA X 26; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188319326
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The following was reported: post-operative screw breakage.The patient accepted atlantooccipital fusion and decompression on (b)(6) 2017.No anomaly was observed in procedure.The patient felt pain when raise her head on (b)(6) 2018.The patient returned hospital and x-ray report indicated screw broke.The revision surgery was operated and broken screw was removed on (b)(6) 2018.Then patient condition changed better.

• Brand Name: MNTR M/L SCREW 3.5 DIA X 26
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7932206
• Report Number: 1526439-2018-50947
• Device Sequence Number: 1914054
• Product Code: NKG
• UDI-Device Identifier: 10705034157689
• UDI-Public: (01)10705034157689
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 188319326
• Device Catalogue Number: 188319326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR