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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI CURVED ROD 80MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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| Catalog Number 498.137 |
| Device Problem
Unintended Movement (3026)
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| Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown rod/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, after the initial operation, the rod unhooked out of the head screw on one side of the c5/c6 location.On the other side of c5/c6, the innie was next to the screw head.No patient status information available.Concomitant devices reported: unknown locking/ set screws: synapse (part # unknown, lot # unknown, quantity # 6), quantity #1), unknown ¿ screws (part # unknown, lot # unknown, quantity #1).This report is for one (1) rod: synapse.This is report 2 of 8 for (b)(4).
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Event Description
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Additional event information it was reported by the customer to make sure that the two handle with torque limiter ( 2.0 nm) ( 03.614.035) with quick coupling are fully functional and calibrated.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D2: additional device product codes: kwp, mnh, mni.H6: the received images was reviewed, on the received post operative x-rays dated 25.March 2020 is a migrated pedicle screw head at the lower end of the construct visible.Therefore is the complaint rated as confirmed.Products were not returned and no article- and lot numbers was provided.Therefore no further evaluation is possible.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.
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Event Description
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It was further reported that the original implantation date was (b)(6) 2020.The screws are ok and not torn out.The rod on the left side slipped out of the screw head (th1) and on the right side the innie lies next to the screw (th1).The pull-out force was probably too big.A revision surgery is not performed.Concomitant devices reported: rod ø3.5 prebent l80 tan gold (part # 498.137, lot # unknown, quantity 1); lockscr synapse tan (part # 04.614.508, lot # unknown, quantity 2); cancellousscr synapse ø4 l36 tan (part # 04.614.136, lot # unknown, quantity 2).This report is for one (1) 3.5mm ti curved rod 80mm.This is report 2 of 6 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
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