MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT

Catalog Number UNK_SPN

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 05/19/2014

Event Type  Injury  

Event Description

It was reported that a call was received from an individual who wanted to determine if their acp had been recalled previously.They had an anterior fusion in 2002 from c4-7 at (b)(6).Additionally the individual had previous anterior fusions, posterior fusions and thoracic resections.For this surgery, cadaver bone was used as spacers.The individual also complained that currently they can feel one screw is backing out and was complaining of pain.

Manufacturer Narrative

Method: device not returned; results: no part number, lot number and/or product information was provided.In addition, product was not returned, so no cause can be determined.Conclusion: the reported event of a screw backing out could not be confirmed as the complainant had not visited a doctor and obtained an xray confirming the complaint of a screw backing out.No part number, lot number and/or product information was provided.There were no recalled products in 2002 when this was implanted and this information was relayed to the complainant.

Event Description

It was reported that a call was received from an individual who wanted to determine if their acp had been recalled previously.They had an anterior fusion in 2002 from c4-7 at the (b)(6) hospital.Additionally the individual had previous anterior fusions, posterior fusions and thoracic resections.For this surgery, cadaver bone was used as spacers.The individual also complained that currently they can feel one screw is backing out and was complaining of pain.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNK
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401 336
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401 336
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3851156
• MDR Text Key: 16224893
• Report Number: 0009617544-2014-00256
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/19/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2014
• 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 Outcome(s): Required Intervention