MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 125MM; ORTHOSIS,SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	498.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: mni kwp kwq nkb.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).A device history record (dhr) review was conducted: part number:498.105.Synthes lot number: h753045.Supplier lot number: n/a.Release to warehouse date: feb 28, 2019 expiration date: n/a manufactured by synthes brandywine no ncrs were generated during production.Device history review.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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) 2020 the patient underwent removal of the posterior universal spinal system (uss) followed by an anterior corpectomy of due to a broken hard rod.The patient was originally implanted with a uss system on an unknown date and there were no screws implanted.At an unknown time after the initial surgery, the patient broke the right hard rod just cranial to the right unknown screw.It is unknown how the broken hard rod was discovered.During the revision, the surgeon placed a stryker v-lift expandable cage.The surgeon then flipped the patient to a posterior position and removed all the synthes uss hardware and as verified the right hard rod was broken.The surgeon then placed the new unknown screws a.The surgeon also used depuy synthes spine expedium system and did not replace the screws at as the surgeon felt that the patient doesn't need them.There was no patient consequence reported.Concomitant devices reported: unknown hooks (part# unknown, lot # unknown, quantity # unknown).Unknown collar (part# unknown, lot # unknown, quantity # unknown).Unknown nuts (part# unknown, lot # unknown, quantity # unknown).Unknown uss screws (part # unknown, lot # unknown, quantity 3).Unknown transverse bar (part # unknown, lot # unknown, quantity # unknown).Unknown parallel connectors (part # unknown, lot # unknown, quantity # unknown).Unknown low-profile trans connector (part# unknown, lot # unknown, quantity # unknown).Unknown trans connector assemblies (part# unknown, lot # unknown, quantity # unknown).Unknown staples (part # unknown, lot # unknown, quantity # unknown).Unknown washers (part # unknown, lot # unknown, quantity # unknown).This complaint involves 1 device.This report is for (1) 6.0mm ti hard rod 125mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 125MM
• Common Device Name: ORTHOSIS,SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10291980
• Report Number: 2939274-2020-03255
• Device Sequence Number: 13655978
• Product Code: MNH
• UDI-Device Identifier: 10705034788869
• UDI-Public: (01)10705034788869
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: 498.105
• Device Catalogue Number: 498.105
• Device Lot Number: H753045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR