MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 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	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The mountaineer inner screw was not returned to the customer quality unit for evaluation.A review of the device history record (dhr) could not be performed as the lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device we are unable to confirm the reported issue or identify the root cause.Device was not returned for evaluation, thus unable to confirm the reported issue.Complaint will be closed at this time with no further action.If additional information or the product is returned, a follow up will be filed.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
Dr.(b)(6) performed a c3-t1 fusion on the patient on (b)(6) 2017.Lateral mass screws, 3.5mm in diameter and 12-14mm in length, were placed bilaterally c3-c6, skipping c7, and bilaterally at t1, 4.0mm in diameter and 30mm in length m/l screws.10 mountaineer set screws and 1 3.5x200mm ti rod were placed in the construct in typical fashion.Set screws were final tightened and the surgery concluded successfully.On (b)(6) 2018, the patient arrived at mayo for revision fusion.The right t1 set screw was noted on x-ray to be floating above the polyaxial head.All other screws and set screws were in their original location.Dr.Elder removed the remaining set screws and the right t1 m/l screw.The remaining screws in the construct were checked for adequate boney fixtion.Dr.Elder proceeded to add 3.5x26mm mountaineer screws to c2 bilaterally and 4.35x35/30 m/l screws bilaterally at t2, and removed all of the lateral mass screws c3-c6, replacing them with 4.0x14mm m/l and green screws.Dr.Elder also removed the original t1 screws bilaterally and replaced them with 4.35x25/30mm m/l screws.14 set screws and 2 3.5x120mm ti rods were placed bilaterally.The set screws were final tightened in typical fashion.During the revision surgery on 2/14, cultures were taken and the results are not yet known.The surgeon also noted the patient had very soft osteopenic bone.Patient consequence? :no is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: MNTR INNER SCREW
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; CH
• MDR Report Key: 7324314
• Report Number: 1526439-2018-50213
• Device Sequence Number: 10790655
• 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 Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/08/2018
• 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: 74 YR
• Patient Weight: 66