MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712640
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/20/2018
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
This surgery was a plf from l4-s1 with a tlif.At some point after the case, the rod disengaged from the head of the screw at l4.The set screw was still fully engaged in the head of the screw where the rod came out.Patient consequence? :yes.Patient consequence description:patient required a revision surgery.Action taken for procedure:no issues during the revision.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: SI POLYAXL SCREW 6 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7777472
• Report Number: 1526439-2018-50781
• Device Sequence Number: 13843002
• Product Code: NKB
• UDI-Device Identifier: 10705034067728
• UDI-Public: (01)10705034067728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 179712640
• Device Catalogue Number: 179712640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/13/2018
• 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: 55 YR
• Patient Weight: 74