MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0 TI PRECON ROD 50MM STR LEN/400MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	04.600.014
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
It was reported that on (b)(6) 2021, the patient underwent revision surgery due to two broken titanium precon rods.Initially, the patient had a t6 to ilium posterior spine fusion on an unknown date in 2016.At an unknown point in time, the patient bilaterally broke both rods.It is unknown how it was discovered.The rod was broken at the l3 and l4 level.The surgeon then contoured new rods and reconnected them to the existing screws from t6-ilium.The procedure was successfully completed.It is unknown if there was surgical delay.There was no patient consequence.This report is for (1) 6.0 ti precon rod 50mm str len/400mm this is report 2 of 2 for (b)(4).

• Brand Name: 6.0 TI PRECON ROD 50MM STR LEN/400MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12172777
• Report Number: 2939274-2021-04105
• Device Sequence Number: 937042
• Product Code: KWP
• UDI-Device Identifier: 10705034734118
• UDI-Public: (01)10705034734118
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 04.600.014
• Device Catalogue Number: 04.600.014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR