MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, STR, TI, 450MM (HX END); ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179963450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/16/2019
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
It was reported that the patient had t9-pelvis posterior spinal fusion surgery on (b)(6) 2016.During a routine clinic follow up visit on (b)(6) 2019, it was found that patient had broken rods (part 1799-63-450) at l3 and a fractured screw (part 1799-12-899) at the right ilium.Likely cause was non-union at l2-3.X-ray and ct scans were done to confirm.Revision surgery occurred on (b)(6) 2019.Broken hardware was removed and revised to correct the non-union.The implants were discarded by the hospital and are not available to ship to depuy for evaluation.The lot number of these items is not known.Both surgeries occurred at (b)(6) medical center in (b)(6).

• Brand Name: ROD, STR, TI, 450MM (HX END)
• 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: 8609362
• Report Number: 1526439-2019-51638
• Device Sequence Number: 2294433
• Product Code: NKB
• UDI-Device Identifier: 10705034091679
• UDI-Public: (01)10705034091679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 179963450
• Device Catalogue Number: 179963450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: 83 YR
• Patient Weight: 85