MAUDE Adverse Event Report: ZIMMER SPINE CREW, VARIABLE, SELF DRILLING, 14MM; SCREW, VARIABLE, SELF DRILLING, 14MM

Model Number 07.01875.014

Device Problems Loose or Intermittent Connection (1371); Peeled/Delaminated (1454); Malposition of Device (2616); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

Same case as: 2184052-2014-000112.It was reported the screws possibly stripped during surgery.The surgeon was preformed c c3-c5 acdf.During the surgery, the screw at c4 started to feel as though it lost purchase and was "totally spinning" upon advancing in the bone.The hole was prepped with an awl prior to screw placement.The screw at c4 was left and the device locked at c3-c4.When attempting to advance the c5 screw, it felt as though it had bad purchase immediately upon advancing.The screw at c5 was removed and a 14mm self tapping screw was advanced.Again the surgeon felt as though he did not have good purchase and the screw kept spinning.The possibly stripped 14mm screw was left in place and locked the plate.

• Brand Name: CREW, VARIABLE, SELF DRILLING, 14MM
• Type of Device: SCREW, VARIABLE, SELF DRILLING, 14MM
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4001180
• MDR Text Key: 4711868
• Report Number: 2184052-2014-00111
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.01875.014
• Device Catalogue Number: 07.01875.014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR