MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PLATE LARGE; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188362045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 a patient underwent revision of one (1) broken occipital plate due to pain and nonunion on (b)(6) 2018.The patient was implanted with the occipital plate, four unknown screws and unknown quantity of unknown rods (all depuy parts) while undergoing an occipital fusion on (b)(6) 2017.Subsequently, in (b)(6) 2018 the patient complained of pain.A follow-up x-ray confirmed that the occipital plate implanted earlier was broken and that there was a nonunion; hence, on (b)(6) 2018, the broken plate was removed.Patient was revised to a new synthes plate (04.161.011).Unknown screws (qty.4) and rods.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level reveals that the fracture was located along the web feature of the device.Device was then sent for fracture analysis.The fracture analysis report reveals a uniform rough morphology across the entire surface which suggests the device experienced a static overload failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the occipital¿s plate web fracturing cannot be positively determined.However, the fracture analysis report suggests the device experienced a static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MNTR OC PLATE LARGE
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7467853
• Report Number: 1526439-2018-50419
• Device Sequence Number: 1642756
• Product Code: NKG
• UDI-Device Identifier: 10705034158891
• UDI-Public: (01)10705034158891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 188362045
• Device Catalogue Number: 188362045
• Device Lot Number: WA1782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 67 YR