MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN ROD

Catalog Number UNK_SPN

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2009

Event Type  malfunction  

Manufacturer Narrative

Article citation: skov, s.T., li, h., hansen, e.S.Et al.New growth rod concept provides three dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis.International orthopaedics (sicot) 44, 1773¿1783 (2020).Https://doi.Org/10.1007/s00264-020-04604-y.Return status of the device is unknown.

Event Description

Through journal article ¿new growth rod concept provides three-dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis¿ it was reported that 38 children with early-onset scoliosis (eos) were observed under the cody bünger concept.The cody bünger concept ¿combines concave interval distraction and contralateral-guided growth with apical control and to investigate the 3d deformity correction, the spinal growth, and the pulmonary development.¿ ¿mean age was 10.2 years (4.4¿15.8) with a mean follow-up of 5.6 years, and they underwent 168/184 open/magnetic lengthening procedures.Outcomes were as follows: scoliosis, kyphosis, and lordosis angles; apical rotation; spinal length; apical translation; coronal and sagittal vertical alignment; complications; and pulmonary function in a subgroup.Twenty-two out of 38 patients experienced at least one complication.A total of 37 complications during growth treatment was registered: 17 implant-related, four mcgr-related, six wound-related, four alignment-related, and six medical-related.Additionally, five post-definitive fusion complications were reported.Two patients only had medical complications, and 11 patients underwent a total of 13 unintended re-operations.The remaining surgery-related complications were managed during the planned procedures.Two patients with deep infection at the elongation site recovered following surgical debridement and systemic antibiotics.One child with sma died suddenly at home for a reason unrelated to the scoliosis treatment after nearly four years of treatment.Three patients developed a trunk shift that was counteracted by open reverse distraction on the caudal sliding tube.Two of them had cb-mcgr.The five post-definitive complications were as follows: one misplaced pedicle screw in disc (removed), one rod breakage/fusion failure (re-fusion surgery), one case of severe back pain without obvious cause which resolved over a year, one add-on scoliosis, and one proximal junctional kyphosis issue which may require future revision surgery.Scoliosis improved from mean 76° (46¿129) to 35° (8¿74) post-op and was 42° (13¿83) at end of treatment.Apical rotation was reduced by 30% but was partially lost during treatment.Thoracic kyphosis initially decreased by mean 15° and was partially lost during treatment.Lordosis was largely unaltered during treatment.Mean t1-s1 height increased from 30.7 cm (22.7¿39.2) to 34.6 cm (27.8¿45.1) postop and further increased to 38.5 cm (30.1¿48.1) during treatment.This corresponded to a t1-s1 growth rate of 12 mm/year, and positive growth rates were found in all height parameters evaluated.Frontal balance and apical translation improved, whereas sagittal balance was unaltered.Complications occurred in 22/38 patients, and 11/38 had an unintended reoperation.Pulmonary function (fvc and fev) increased but the relative lung function was unchanged.¿ the device information was reported as ¿4.5 xia (stryker, (b)(4), usa) or 4.5/5.5 mesa (k2m, (b)(4), usa), and revere (globus medical, (b)(4), usa)¿; however, it is unknown which devices were implanted in which patients.Implant and explant dates are unknown.No further information has been provided.This report will capture patient 6 who experienced a broken rod 1 year and 8 months post-operatively.The rod was changed during the next scheduled distraction.A review of product history indicates there have been reports of death or serious injury resulting from similar events with this device.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The cause of the event could not be determined because insufficient information was provided.The author of the article was contacted multiple times to provide additional information, however no response was received.Further information such as device details, return of the device, pre- and post-operative x-rays , operative report, patient history and follow-up notes are needed to complete the investigation.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

Event Description

Through journal article ¿new growth rod concept provides three-dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis¿ it was reported that 38 children with early-onset scoliosis (eos) were observed under the cody bünger concept.The cody bünger concept ¿combines concave interval distraction and contralateral-guided growth with apical control and to investigate the 3d deformity correction, the spinal growth, and the pulmonary development.¿ ¿mean age was 10.2 years (4.4¿15.8) with a mean follow-up of 5.6 years, and they underwent 168/184 open/magnetic lengthening procedures.Outcomes were as follows: scoliosis, kyphosis, and lordosis angles; apical rotation; spinal length; apical translation; coronal and sagittal vertical alignment; complications; and pulmonary function in a subgroup.Twenty-two out of 38 patients experienced at least one complication.A total of 37 complications during growth treatment was registered: 17 implant-related, four mcgr-related, six wound-related, four alignment-related, and six medical-related.Additionally, five post-definitive fusion complications were reported.Two patients only had medical complications, and 11 patients underwent a total of 13 unintended re-operations.The remaining surgery-related complications were managed during the planned procedures.Two patients with deep infection at the elongation site recovered following surgical debridement and systemic antibiotics.One child with sma died suddenly at home for a reason unrelated to the scoliosis treatment after nearly four years of treatment.Three patients developed a trunk shift that was counteracted by open reverse distraction on the caudal sliding tube.Two of them had cb-mcgr.The five post-definitive complications were as follows: one misplaced pedicle screw in disc (removed), one rod breakage/fusion failure (re-fusion surgery), one case of severe back pain without obvious cause which resolved over a year, one add-on scoliosis, and one proximal junctional kyphosis issue which may require future revision surgery.Scoliosis improved from mean 76° (46¿129) to 35° (8¿74) post-op and was 42° (13¿83) at end of treatment.Apical rotation was reduced by 30% but was partially lost during treatment.Thoracic kyphosis initially decreased by mean 15° and was partially lost during treatment.Lordosis was largely unaltered during treatment.Mean t1-s1 height increased from 30.7 cm (22.7¿39.2) to 34.6 cm (27.8¿45.1) postop and further increased to 38.5 cm (30.1¿48.1) during treatment.This corresponded to a t1-s1 growth rate of 12 mm/year, and positive growth rates were found in all height parameters evaluated.Frontal balance and apical translation improved, whereas sagittal balance was unaltered.Complications occurred in 22/38 patients, and 11/38 had an unintended reoperation.Pulmonary function (fvc and fev) increased but the relative lung function was unchanged.¿ the device information was reported as ¿4.5 xia (stryker, kalamazoo, michigan, usa) or 4.5/5.5 mesa (k2m, leesburg, virginia, usa), and revere (globus medical, audubon, pennsylvania, usa)¿; however, it is unknown which devices were implanted in which patients.Implant and explant dates are unknown.No further information has been provided.This report will capture patient (b)(6) who experienced a broken rod 1 year and 8 months post-operatively.The rod was changed during the next scheduled distraction.A review of product history indicates there have been reports of death or serious injury resulting from similar events with this device.

• Brand Name: UNKNOWN ROD
• Type of Device: UNKNOWN ROD
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10556915
• MDR Text Key: 262203636
• Report Number: 3004024955-2020-00029
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 19