MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE A6; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189401406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention, medical device removal, device breakage (b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Event: the expedium titanium bars and the sfx broke inside the patient after a fall, which led to the surgical necessity of the same.Medical report: material taken from the atn patient, on (b)(6) 2019, in this hospital by dr.(b)(6).Material was broken, according to x-ray attached, after the patient suffered a fall.I leave the material in the possession of the nurses (b)(6) for later withdrawal from the hospital for our logistics.Sales rep communicated via (b)(6) that the operating company of the materials is depuy spine, of references: titanium rod: 1797-62-300; sfx: 1894-014-06.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SFX,5.5,TI, MED, SIZE A6
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8822060
• Report Number: 1526439-2019-51876
• Device Sequence Number: 14040563
• Product Code: NKB
• UDI-Device Identifier: 10705034168135
• UDI-Public: (01)10705034168135
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 189401406
• Device Catalogue Number: 189401406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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: 75 YR