MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TAYLOR SPATIAL FRAME EXFIX DEV; PIN, FIXATION, THREADED, METALLIC

Catalog Number UNKNOWN

Device Problem Compatibility Problem (2960)

Patient Problem Necrosis (1971)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

"the british editorial society of bone & joint surgery.Children's orthopaedics.Femoro-pedal distraction in staged reconstructive treatment of tibial aplasia." author: a.Laufer et al.In this study there were 10 patients (12 limbs) bearing taylor spatial frame.It was reported that a patient suffered from skin necrosis over hind foot.It is unknown how the event was treated.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the literature review article indicates that a child who was being treated with a tsf for femoro-pedal distraction suffered from skin necrosis over hind foot.It is unknown how the event was treated.Without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be performed, and the patient outcome beyond that which is documented in the article cannot be confirmed.Therefore, no further clinical assessment is warranted at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: UNKN TAYLOR SPATIAL FRAME EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED, METALLIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10938669
• MDR Text Key: 219294390
• Report Number: 1020279-2020-06933
• Device Sequence Number: 1
• Product Code: NDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other