MAUDE Adverse Event Report: SYNTHES UNIVERSAL INTRUMENTATION; RODS

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 09/24/2009

Event Type  Injury  

Event Description

On (b)(6) 2009, (b)(6) chief of spine services and medtronic consultant dr (b)(6) performed l4-5, l5-s1 two-level lumbar fusion with large ii infuse bone graft in combination with two integra hollywood nanometalene interbody cage spacers and synthes/universal instrumentation (rods, screws, connectors).Seaspine and stryker sales reps were in attendance during operative procedure.Pt developed post-operative complications that health care providers failed to disclose were attributed to known complications associated with improper dosage/preparation of rhbmp-2/acs sponge components of the combination product used in indications not cleared by the fda, including but not limited to permanent posterior bone resorption at l4-s1 and heterotopic bone growth that escaped out of the cages at both levels around the dura and the transversing nerve root.Pt requires revision surgery decompression and removal of heterotopic bone growth at both levels.On information and belief the infuse bone graft combination product pma 000058 was adulterated and misbranded "when it the lt-cage component was unbundled and rebundled with the integra hollywood nanometalene interbody cage." not fda cleared to be introduced into interstate commerce until may 2011 under k102026.

• Brand Name: UNIVERSAL INTRUMENTATION
• Type of Device: RODS
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 3806961
• MDR Text Key: 4523626
• Report Number: MW5036046
• Device Sequence Number: 4
• Product Code: KWP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 59