MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VARIABLE, SELF-DRILLING SCREW 4.0X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186850016

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the device history record (dhr) could not be performed on the two variable self-drilling 16mm screws (product code: 1868-50-016, lot number(s): unknown) as no lot numbers were provided.Since these screws were not returned, no lot numbers could be taken directly from the samples.Without the lot numbers, no review of their manufacturing records could be completed.A trend analysis was conducted.No further actions from trending analysis are required.Without the device we are unable to confirm the reported issue or identify the root cause.If the device is returned at a later date, the complaint will be reopened and the sample will be evaluated.No systemic trends requiring immediate action have been observed, 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.Sample not available.

Event Description

Dr.(b)(6) performed a 3 level acdf on this patient around 6 weeks ago.After post-op x-rays were obtained, the top two screws had backed out of the 3 level skyline plate.Dr.(b)(6) bent the top of the plate during the initial procedure due to strange patient anatomy.He does not believe they backed out due to implant failure but because of poor bine quality and strange anatomy of c4.Revision procedure was performed to remove c4 screws.

• Brand Name: VARIABLE, SELF-DRILLING SCREW 4.0X16MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6079095
• MDR Text Key: 59174916
• Report Number: 1526439-2016-10821
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186850016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 59