MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 3.5DIA X 28MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188318328
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the inner screw of the screw backed out - could not inserter the screw.Patient consequence? : no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the returned device found that the screw¿s tulip head inner cap had disassembled from its intended location.No damage was present on the screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the screw¿s inner cap becoming rotated from its intended position cannot be positively determined.However, noted damage suggests that unanticipated high amount of forces was placed on the tulip head resulting in the inner cap becoming disassembled from its intended location.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 F/A SCREW 3.5DIA X 28MM
• 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: 8006344
• Report Number: 1526439-2018-51016
• Device Sequence Number: 11145776
• Product Code: NKG
• UDI-Device Identifier: 10705034157252
• UDI-Public: (01)10705034157252
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 188318328
• Device Catalogue Number: 188318328
• Device Lot Number: 204916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1