MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 6X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186760445
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
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
Viper prime cortical fix screw disassembled and prevented rod from reducing.This required removal of rod and 2 additional screws to correct the issue.New screws were used.Patient consequence?: yes.Patient consequence description:additional incision size was needed and approximately 45 min was added to procedure.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.Additional clarification from sales rep: the internal mechanism of the poly feature was no longer where it was supposed to be.The other screw had part of the thread shear off preventing a set screw from engaging.This was noticed after rod removal and attempts to replace set screw were unsuccessful.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the viper prime 6 x 45mm screw confirms the saddle was dislodged from its intended position.No other anomalies could be identified from the returned screw.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.The root cause of the screw falling apart cannot be determined from the sample and the information provided.A potential root cause may be force inadvertently placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the screw disassembling during use.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: VIPER PRIME CFXFEN XTAB 6X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7341782
• Report Number: 1526439-2018-50241
• Device Sequence Number: 1657705
• Product Code: NKB
• UDI-Device Identifier: 10705034509402
• UDI-Public: (01)10705034509402
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 186760445
• Device Catalogue Number: 186760445
• Device Lot Number: TBRZZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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: Other