MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186717645
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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,during compression manouvers, the monoaxial screw (the most proximal) twisted.The rod was already inserted, so the problem was not related with the reduction of the screw; that was easily done.Was surgery delayed due to the reported event? no, action taken when event occurred? reduction of the compression applied, was procedure successfully completed? yes, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, other information: apparently the screw did not break, but could be a possibility.The patient will be closely supervised, 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, (b)(4), device property of? none, device in possession of? none, 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).Device was not returned for evaluation.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.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER MONO SCREW 6X45MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8371591
• Report Number: 1526439-2019-51389
• Device Sequence Number: 1097916
• Product Code: NKB
• UDI-Device Identifier: 10705034123479
• UDI-Public: (01)10705034123479
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• 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
• Report Date (Section B): 01/31/2019

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: 186717645
• Device Catalogue Number: 186717645
• Device Lot Number: RL260439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: Other
• Patient Age: 25 YR