MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM 5.50 POLYAXIAL EXTENDED TAB SCREW 5.00X30MM, SS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 188132530

Device Problems Break (1069); Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 02/24/2014

Event Type  Injury  

Event Description

The patient developed an infection and was brought in for a revision surgery to clean, debris, and inspect.The surgeon determined the infection to be localized unilaterally and on one screw in particular with migration to the two screws proximal and distal.He decided that the best course of action was to remove the hardware unilaterally.Upon removal of the hardware it was discovered that 2 screws were defective, the heads had come detached from the shank.It was unclear as to when the screw heads had become detached.However, the sales rep believes the surgeons think the heads became detached prior to the revision surgery and they were discovered in the surgery.These two screws were not screws that contained infection.The construct was t3-l2 and the 2 screws came from r t9 & t8.The following mfg medwatch reports are being filed for the three screws that were involved in this event: mfg medwatch report no.1526439-2014-11396 (infection and migration); mfg medwatch report no.1526439-2014-11397 (first screw with screw head separated from shank); mfg medwatch report no.1526439-2014-11398 (second screw with screw head separated from shank).

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Visual inspection of expedium 5 x 30mm polyaxial extended tab screw revealed that the head, saddle, and body had been completely separated from one another.Indications were observed suggesting that the saddle had been swaged.The saddle showed signs of abrasion on the screw head side.A dhr review identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A twelve month complaint trend analysis found no emerging trends.No corrective action is required as there has been no issue identified in the manufacturing or release of the device and there has been no observed systemic trend.Therefore, the complaint 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: EXPEDIUM 5.50 POLYAXIAL EXTENDED TAB SCREW 5.00X30MM, SS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3688314
• MDR Text Key: 4243151
• Report Number: 1526439-2014-11398
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 188132530
• Device Lot Number: RL141390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 18 YR