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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); 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
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
• 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: 9140232
• Report Number: 1526439-2019-52175
• Device Sequence Number: 2941688
• Product Code: NKB
• UDI-Device Identifier: 10705034070087
• UDI-Public: (01)10705034070087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 179722050
• Device Catalogue Number: 179722050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/01/2019
• 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