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	Pain (1994); No Code Available (3191)
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
Revision t5-pelvis : dr (b)(6) hospital, (b)(6) 2019.The patient had bilateral broken rods at l3 over old pso site.Patient history: on (b)(6) 2014 patient had removal of harrington rods - "post harrington flat back", and implants placed, t5-pelvis, with a cage inserted at l5/s1.There were temporary rods placed over the cage, l5-s1,until the stage 2 operation when the final rods will be placed.On (b)(6) 2014: stage 2.Pso (pedicle subtraction osteotomy) performed at l3 and then the rods and set screws inserted from t5-pelvis.There were also, x 2 cross connectors placed on the construct.On (b)(6) 2019: patient had experienced pain, was seen by dr cree and x-rays taken.Surgery planned to replace the broken rods and set screws.On (b)(6) 2019: in surgery, it was noted that there was movement where the old pso site was, l3, "non union" so the set screws and rods were removed, screws replaced at l2, l4,l5 and s1 and then new rods and set screws put in place.He also placed an "outrigger" construct, at l3, another rod connected by open/closed connectors, that run beside the total rod length.Female patient initials: (b)(6) years old, dob:(b)(6) 1955.This complaint involves 2 devices as impacted products with 10 concomitant devices.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).

• 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: 8831084
• Report Number: 1526439-2019-51888
• Device Sequence Number: 3294857
• Product Code: NKB
• UDI-Device Identifier: 10705034295305
• UDI-Public: (01)10705034295305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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
• Patient Age: 63 YR