MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP5.5 385MM CONTOUR COCR ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196791385
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189); No Code Available (3191)
Date of Event	07/31/2018
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: revision t3-pelvis - broken rods; andrew cree westmead private hospital 31-7-2018.Primary implant date: (b)(6) 2016.Dr cree was performing a revision spinal fusion for broken rods at l3/4 (r) and l4/5 (l).As stated, this was due to a probable non-union.He removed the screws and broken rods from l2-5 on both sides and replaced them with new screws and rods.He then connected the new rods to the proximal fusion by using connectors on both sides.

• Brand Name: EXP5.5 385MM CONTOUR COCR ROD
• 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: 7790473
• Report Number: 1526439-2018-50806
• Device Sequence Number: 11142418
• Product Code: NKB
• UDI-Device Identifier: 10705034295305
• UDI-Public: (01)10705034295305
• Combination Product (Y/N): N
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 196791385
• Device Catalogue Number: 196791385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/16/2018
• 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: 78 YR