MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	828-083
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Concomitant medical products: product id: 76446540, lot#: (b)(4), product description: bone screw, 76446540 mult axial 6.5x40 ti, implanted date: (b)(6) 2017, explanted date: (b)(6) 2020.Product id: 76446540, lot#: (b)(4).Product description: bone screw 76446540, mult axial 6.5x40 ti, implanted date: (b)(6) 2017, explanted date: (b)(6) 2020.Product id: 76446545, lot#: (b)(4).Product description: bone screw 76446545, mult axial 6.5x45 ti, implanted date: (b)(6) 2017, explanted date: (b)(6) 2020.Product id: 76446545, lot#: (b)(4), product description - bone screw 76446545, mult axial 6.5x45 ti, implanted date: (b)(6) 2017, explanted date: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received field representative regarding patient with posterior instrumented arthrodese t12 s1 for a degenerative discopathy involved in synthesis and replacement.Levels implanted - t12 s1.It was reported during normal use, patient reported that in (b)(6) he perceived a loud deaf noise in his back and severe pain on the day of hospitalization.Rx tests were carried out and the 2 rods were found to be broken.The 2 broken rods and their intact screws have been removed and replaced.Even if the bars had been intact they would have replaced them equally.There was no broken fragments left in the patient.Patient is alive - no injury.On 2020-jan-04, received additional information that there was no malfunction with the reported bone screws.Patient was not hospitalized prolong as a result of the event.There was no delay in overall procedure time.There were no complications reported as a result of the event.Procedure was completed in patient without problem.Customer refused to return the product as they intended to keep it.

• Brand Name: TSRH SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 11138902
• Report Number: 1030489-2021-00028
• Device Sequence Number: 846267
• Product Code: KWP
• UDI-Device Identifier: 00673978048680
• UDI-Public: 00673978048680
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K880215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 828-083
• Device Catalogue Number: 828-083
• Device Lot Number: 0439276W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/08/2021
• 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: Required Intervention
• Patient Age: 61 YR