MAUDE Adverse Event Report: ORTHOFIX INC 2212, SPINAL-STIM, OSTEOGENESIS STIMULATOR; PEMF - SPINAL STIM

Catalog Number	652212-0017
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
Information provided states that patient began using the spinal stimulation unit in (b)(6) 2016.Pt stated that she began experiencing pain on (b)(6) 2016 in the same area that she had shingles when in her 20's.Pt saw infectious disease doctor and was told that she had 2nd degree burns.

• Brand Name: 2212, SPINAL-STIM, OSTEOGENESIS STIMULATOR
• Common Device Name: PEMF - SPINAL STIM
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5664606
• Report Number: 3008524126-2016-00013
• Device Sequence Number: 510760
• Product Code: LOF
• UDI-Device Identifier: 18257200080793
• UDI-Public: 18257200080793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/18/2016

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 652212-0017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2016
• Initial Report FDA Received Date: 05/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR