MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNITIZED DI SET SCW, TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179722050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Type  Injury  

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 Description

Event date: (b)(6) 2019, 4 pm. Event description: broken rods and metallosis. Date j&j became aware: (b)(6) 2019, 4 pm. Name of reporter: (b)(6). Hospital name: (b)(6). Hospital town: (b)(6). Product: cocr 5. 5 mm rod, di expedium screws, unitised set screws, connector lot/batch/exp: unknown. Product number: 179774555, 179722050, 179722644, 198769480. Did the event happen during a procedure? no. Were you in the procedure at the time of the event? yes. Was the product being used in a clinical trial? no. Event outcome/how was it managed? rods replaced, blood was not used when sediment discovered. Was there a patient impact or was the procedure due to the failure? patient has metallosis. Has the reporter facility indicated there may be legal action? no. Is the product available for return? hopefully if returned from sterilisation successfully. Please give a detailed explanation of the event: the patient was undergoing revision surgery in which the cocr rods had snapped on both the left and the right side. The surgeon removed set screws, rods connectors and screws. Upon removal of the metal work, there was considerable metallosis on the patient¿s tissue. The anesthetist was using cell salvage to give back the patient, their own blood. Upon spinning down and giving back the blood to the patient, dr (b)(6) (the anesthetist) noticed, metallic, lumpy, greasy components in the patient¿s blood. It is thought this is from the metallosis. Blood samples have been sent for biochemical analysis in (b)(6). Surgeon name; mr (b)(6). This complaint involves five (5) devices.

• Brand Name: UNITIZED DI SET SCW, TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9140232
• Report Number: 1526439-2019-52175
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034070087
• UDI-Public: (01)10705034070087
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 179722050
• Device Catalogue Number: 179722050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Outcome(s): Required Intervention