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

Model Number	188342200
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 that the post surgery x-ray showed a loosened mountaineer set screw patient consequence? :yes.Patient consequence description: revision surgery.Action taken for procedure:revision surgery on (b)(6) 2018.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
(b)(4).Visual examination of the inner screw revealed signs of operative use as evidence by significant wear and damage to the inner screw.It was noted that the rod striations were observed on the inner screw.The initial threads on the inner screw had become torn off.A review of the device history record could not be conducted as the lot number is illegible.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the inner screw threads becoming torn off cannot be positively determined.However, the noted damage suggests that inadvertently cross threading of the inner screw occurred upon insertion into the tulip head.It should be noted that the tightening the inner screw when it is cross threaded places force on the inner screw and the tulip head¿s threads that can result in them being torn off.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 INNER SCREW
• 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: 7891396
• Report Number: 1526439-2018-50896
• Device Sequence Number: 11221871
• Product Code: NKG
• UDI-Device Identifier: 10705034158693
• UDI-Public: (01)10705034158693
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 188342200
• Device Catalogue Number: 188342200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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: 83 YR