MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 4.0 DIA X 24; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188318424
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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
After putting a pedicle screw the surgeon noticed that the screw head loosened.Was surgery delayed due to the reported event?: unknown.Was procedure successfully completed?: unknown.Were fragments generated?: unknown.If yes, were they removed easily without additional intervention?: unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).The returned device was received assembled with no obvious damage to the screw threads or the screw head.The screw and screw head both showed signs of wear.The drag spring (ring) component appeared to be deformed and did not sit flush in the screw.Upon disassembly, it appeared that the screw head cap component was missing from the screw head.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.Although no definitive root cause could be determined for the missing component, it is possible that the device experienced unintended forces which lead to the disassembly of the screw head cap.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, 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 F/A SCREW 4.0 DIA X 24
• 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: 8821205
• Report Number: 1526439-2019-51867
• Device Sequence Number: 3109586
• Product Code: NKG
• UDI-Device Identifier: 10705034157450
• UDI-Public: (01)10705034157450
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188318424
• Device Catalogue Number: 188318424
• Device Lot Number: ALKC25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 09/26/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/24/2019; 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1