MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 300 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179762300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Surgical intervention in the form of revision surgery.(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
It was reported a revision from t10-pelvis for bilateral broken rods due to non-union at l5/s1.The rod had broken above s1 on the right and below s1 on the left.Surgeon removed the rods on both "side", replaced the screws at l)4, r) and then both sides at l5 and s1 and the iliac screw, r).Surgeon has a routine of replacing the screws that are nearest the break to the rod.There was no fault of the screws.Revision t10-pelvis.Primary implant date: (b)(6) 2014.

• Brand Name: ROD, 300 MM
• 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: 8016348
• Report Number: 1526439-2018-51023
• Device Sequence Number: 19177909
• Product Code: NKB
• UDI-Device Identifier: 10705034077420
• UDI-Public: (01)10705034077420
• Combination Product (Y/N): N
• PMA/510(K) Number: K033901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 179762300
• Device Catalogue Number: 179762300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/29/2018
• 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: 68 YR